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Conclusion | non-PCOS, PCOS | Follicular homocysteine is a suitable reporter that might be investigated as a tool for oocyte-embryo selection. A diet enriched with methyl donors may be useful in PCOS and supplements may also help. These findings may be also true for non-PCOS women, which warrants investigation.The study was approved by the Acibadem University Research Ethics Committee (2017–3-42). Clinical trial retrospective registration number ISRCTN55983518. | PMC10371946 | |
Keywords | PMC10371946 | |||
Introduction | endocrine disorder, PCOS, infertility, metabolic derangements | POLYCYSTIC OVARY SYNDROME, OVARIAN HYPERSTIMULATION, DEGENERATION, ENDOCRINE DISORDER | Homocysteine (Hcy) is a non-proteogenic amino acid resulting from (adenosyl)methionine de-methylation in transmethylation reactions. Due to the wide involvement of carbon unit trafficking in animal metabolism, Hcy is massively and continuously produced within cells with one-fifth to one-sixth of the total Hcy pool renovated every hour [The OCM is fundamental for gametogenesis and embryogenesis. Methylations are necessary to ensure DNA methylation as part of the epigenetic programming as well as for key molecular syntheses and in general for tissue growth and differentiation. The endogenous antioxidant system supported by GSH is in turn necessary to neutralize the reactive oxygen species (ROS) generated in mitochondria, thus protecting the gametes and embryo DNA from oxidative degeneration. Accordingly, HHcy has been linked to defective gametogenesis in both sexes and to couple infertility [Polycystic ovary syndrome (PCOS) is an endocrine disorder occurring in up to 20% of women in reproductive age [HHcy has been shown to mark a worst reproductive prognosis in PCOS women undergoing intra-uterine insemination (IUI). In a IUI trial [Berker et al. (2009) found that a higher amount of Hcy in follicular fluid of PCOS women undergoing oocyte pick-up following FSH stimulation sharply marked lower oocyte quality, fertilization rates, embryo quality, and pregnancy rates with no pregnancies occurring in women whose sampled follicles contained more than 8 μmolar Hcy [Excess of Hcy is removed by three alternative pathways (Fig. Pathways for homocysteine removal. Any excess of Hcy is toxic and must be eliminated. On the other side, homocysteine is the substrate for other syntheses and a balanced partitioning among the available pathways is essential to avoid metabolic derangements. Hcy can be re-methylated to methionine/SAMe using the methyl group from 5MTHF/CH3B12 (①) under the sequential actions of MTRR and MS. In alternative, it can be re-methylated by BHMT using the methyl group from betaine (②), which happens mainly in the liver. Finally, Hcy can be transsulfurated to cysteine by the sequential action of CBS and CSE (③). The latter enzymes exert an ambiguous recognition of their substrates and may work in a reverse manner (alternative transsulfurations) using cysteine and Hcy to release the reducing gasotransmitter Hydrogen sulfide (HThe present study was intended to preliminarily explore the role of follicular Hcy in predicting the reproductive potential of oocytes, i.e., their ability to generate a viable blastocyst, in assisted reproduction cycles and the ability of a micronutrient support to decrease Hcy concentration in the follicular fluid of PCOS women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction purposes. | PMC10371946 |
Methods | PMC10371946 | |||
Study design, inclusion criteria, and randomization | primary infertility, PCOS | PRIMARY INFERTILITY | This was a prospective, randomized, parallel group, open label, controlled versus no treatment clinical study. The study was approved by the Acibadem University Research Ethics Committee. Clinical trial retrospective registration number ISRCTN55983518.The patients were enrolled between April 2017 and February 2022. The study enrolled women aged more than 18 with primary infertility for at least 1 year, diagnosed PCOS according to the Rotterdam criteria [ | PMC10371946 |
Study procedures | ADVERSE EVENTS | The patients randomized for the treatment arm also received instructions on how to assume the supplement and how to report on adverse events. They assumed one tablet per day of a supplement containing essential or conditionally essential micronutrients in support to the OCM including: betaine 200 mg, l-cystine 200 mg, chelated zinc 10 mg, niacin (vit. B3) 16 mg, pyridoxine (vit. B6) 1.4 mg, riboflavin (vit. B2) 1.4 mg, 5-methyl-tetrahydrofolate (5MTHF) 400 μg, and methylcobalamin (CHAll patients underwent COH according to the standard practices of the study site for the same patients without any study-intended adjustments. Briefly, patients received 150 IU of rFSH daily until day 5; thereafter, the FSH dose was adjusted according to the patient’s response. When the leading group of follicles reached 13 mm, a GnRH antagonist was commenced to inhibit premature LH surge. Once at least 3 follicles reached 18 mm diameter, a bolus of rhCG was injected to induce final maturation. The oocyte pick-up was performed 35–36 h post hCG injection by US-guided transvaginal needle aspiration. The fluid contained in each punctured follicle was collected immediately after aspiration and placed on ice until centrifugation to eliminate any cells and frozen at − 20. Mature oocytes were injected with the partner sperm and fertilization was confirmed by the appearance of two pronuclei. The zygotes were cultured up to blastocyst stage. The best embryo based on morphological score was selected for the fresh embryo transfer. All patients received luteal support with micronized progesterone, 600 mg per day, vaginal route.The follicular fluid samples corresponding to the oocytes that generated the blastocysts selected for transfer were thawed and analyzed for Hcy content. The concentration of Hcy in follicular fluids was tested by a commercially available ELISA kit (Sunred Bio, China) with a sensitivity range of 0 to 155 μmol/L, an intra-assay variability < 10%, and inter-assay variability < 12%. The follicular fluid samples of concern were thawed and tested at a single laboratory all together after the completion of the follow-up of the last enrolled patient. | PMC10371946 | |
Clinical endpoints | Biochemical pregnancy rates were calculated as the rate of patients with positive beta-hCG 7 days post embryo transfer out of the number of patients receiving an embryo transfer. Implantation rates were calculated as the number of gestational sacs observed at vaginal ultrasound 7 weeks after transfer out of the number of transferred embryos. Clinical pregnancy rates were calculated as the rate of patients with fetus heart activity beyond 7 weeks of gestation out of the number of patients receiving an embryo transfer. | PMC10371946 | ||
Statistical analysis | This was a pilot study and, in the absence of previous data to build a statistical hypothesis, the sample was not statistically sized. The inclusion of 40 patients, 20 per group, was believed to be a clinically significant sample allowing to calculate the sample size for any future larger studies. Assuming a drop-out rate post-randomization of 20%, a total of 48 patients (24 per group) was randomized.Categorical data were summarized by absolute frequencies and tested by the chi-square tests with Yates’ correction. Continuous data did not show a normal distribution, therefore they were summarized by median and interquartile range (IQR) and tested by Wilcoxon Rank-sum tests. Statistical computations and visualizations were carried out by R-studio (2022.07.2), which is the integrated development environment of R. In all analyses, a | PMC10371946 | ||
Results | ADVERSE EVENTS | Five patients, all from the intervention group, withdrew their consent to the study post randomization so that 43 patients completed the study: 19 in the intervention group and 24 in the control group. None of the patients consuming the supplement reported adverse events.The demographic and baseline characteristics of the two groups of patients are reported in Table Demographic and baseline characteristics of patientsContinuous data are presented as median (IQR) and analyzed by Wilcoxon rank sum test (W). Categorical data (smoking) are summarized by absolute frequencies and analyzed by chi-square tests (The stimulation and clinical outcomes are summarized in Table Stimulation and clinical outcomesContinuous data are presented as median (IQR) and analyzed by Wilcoxon rank sum test (W). Categorical data (pregnancy rates) are summarized by absolute frequencies and analyzed by chi-square tests with Yates’ correction (A positive beta-hCG at 7 days after embryo transfer was recorded in 12 out of 24 patients (50%) in the control group compared to 15 out of 19 patients (79%; The follicular concentration of Hcy showed a negative correlation with the clinical pregnancies ( | PMC10371946 | |
Funding | The study was partially funded by Partogen Ilac, Turkey, covering the cost for the external laboratory running Hcy detection in follicular fluids. | PMC10371946 | ||
Declarations | PMC10371946 | |||
Ethics approval | The study was approved by the Acibadem University Research Ethics Committee (2017–3-42). Clinical trial retrospective registration number ISRCTN55983518.
| PMC10371946 | ||
Competing interests | AK reports personal fees from Partogen Ilac, outside the submitted work. MD reports personal fees from Parthenogen SAGL, outside the submitted work; in addition, MD is inventor of the pending patents “Dietary supplementation to achieve oxy-redox homeostasis and epigenetic stability” and “Combination of micronutrients to stimulate the endogenous production of hydrogen sulfide (H | PMC10371946 | ||
References | PMC10371946 | |||
Background | death, injury or disease and failure, infection, fractures, blisters | INFECTION | The main activity of the skin is to create a protective barrier against damage. Loss of the skin due to injury or disease and failure to regenerate the affected area may result in disability, infection, or even death. We conducted a clinical trial to evaluate the therapeutic effect of dressing containing silver in process of healing skin blisters caused by limb fractures. | PMC10148518 |
Method | blisters, skin blisters, fractures, pain | This is a pioneering randomized trial that compares the effectiveness of two dressings containing silver (Ag coat) and Gaz Vaseline among patients with skin blisters due to bone fractures who were randomly selected from patients referred to the Kashani Medical Training Center. There were two treatment groups containing 16 patients treated with Ag coat and 15 patients treated with Gaz Vaseline. Pictures were taken of blisters on days 0, 7, and 14 to evaluate the healing process. The amount of pain, duration of the visit (measured by minutes), and general condition of the wound were checked. The amount of pain, duration of visit (measured by minutes) and general condition of the wound was checked. All continuous and categorical data are presented as mean ± standard deviation (SD) and frequency (percentage), respectively. Paired sample T-test and repeated measure analysis of variance (ANOVA), Chi-squared test was used. All pictures were analyzed by Mosaic soft ward. | PMC10148518 | |
Result | During this study, there was no significant difference between the mean of age and BMI and frequency of gender in the two study groups ( | PMC10148518 | ||
Conclusion | decreases pain | In conclusion, Ag coat dressing, not only has a significant effect on wound healing but also, decreases pain, shorter visit time, and its more cost-effective. | PMC10148518 | |
Keywords | PMC10148518 | |||
Introduction | tissue disorders, tissue injury, Fracture blisters, fracture, fibrosis, burns, infection, fractures, fracture blisters, blisters, skin damage | INFILTRATION, SCAR, FIBROSIS, PATHOPHYSIOLOGY, INFECTION, COMPLICATIONS | Investigating the intricate healing process of wounds is essential to understand the multifaceted nature of the wound environment and its complexity. Preclinical models, such as those used in mice, rabbits, and pigs, can be used to simulate different types of wounds, including acute and impaired ones. To ensure reproducible results during a study, investigators must select appropriate methods for monitoring wound progression. This includes non-invasive protocols such as wound tracing, photographic documentation (including image analysis), biophysical techniques, and/or invasive protocols that require wound biopsies. Wound healing is a complex process involving multiple cell types, cytokines, mediators, and the vascular system. It is the skin's way of protecting the body from environmental damage. Recent research has allowed us to better understand how wound healing works and take effective steps toward better wound care. Studies have shown that immune cell infiltration and messaging play a significant role in scar formation and fibrosis [Orthopedic surgeons must be aware of the pathophysiology and management options of fracture blisters, as these can significantly affect the outcome for patients. These blisters, which can appear between 6 and 72 h post-injury, can delay definitive fracture treatment and increase the risk for postoperative wound complications. Therefore, it is essential to have a comprehensive understanding of fracture blisters and their management options to achieve a satisfactory result [Open fractures due to severe soft tissue disorders which may lead to devastating complications are considered an orthopedic emergency. Also, closed fractures, especially fractures due to high-energy mechanisms, are often associated with severe soft tissue injury. Researches show that a negative impact on the outcome of patients is because of soft tissue damage, especially skin damage as the first skin defense barrier. In particular,Fracture blisters, develop as a sign of significant tissue damage and appear between 6 to 72 h after injury. They can delay the treatment of definitive fractures for a considerable time and simultaneously increase the risk of postoperative wound complications [In recent years, dressings with different compositions have been introduced to protect and accelerate the healing of skin damage caused by burns, fractures, and other accidents leading to skin damage. Recently, bacterial cellulose (BC) has been used in dressings to reduce the duration of wound healing [Recent studies reported the effect of dressing containing Silver on the healing process of burn wounds, healing at the skin graft site, reducing the risk of infection and hospitalization, and its cost-effectiveness. The present study aimed to investigate the effect of Agicoat silver Nano-Crystalline Dressing dressing, produced by Emad Pharmaceutical Company, on blisters caused by bone fractures. | PMC10148518 |
Method and material | PMC10148518 | |||
Study desgine | skin blisters, fracture, Hemorrhagic, fractures, blisters, Fractures | PAD, SENSITIVITY | This is a clinical trial study conducted according to the guidelines of the Ethical Committee of Isfahan University of Medical Sciences (Ethics code: IR.MUI.MED.REC.1401.025, Iranian Registry of Clinical Trials (IRCT) code: IRCT20221207056744N1). Eligible patients attending the Orthopedic Clinic of Isfahan Research Center, Isfahan, Iran, between 2021, and 2022, were randomly assigned. The date of sending the article to the research vice-chancellor of the Esfahan university of medical science was 15/10/2021, Faculty approval date was 23/02/2022, the date of obtaining the ethics code was 17/04/2022, University approval date was 22/05/2022, and registration of our trial protocol under the scientific mentioned name has been approved in Iranian Registry of Clinical Trials at 08/01/2023. our registration reference is IRCT20221207056744N1.This is a double-blinded pioneering randomized trial that compares the effectiveness of two dressings containing silver (Ag coat) and Gaz Vaseline among patients with skin blisters due to bone fractures who were randomly selected from patients referred to the Kashani Medical Training Center. All fractures were closed in the lower extremity. Fractures are all simple in both groups. The communitive fractures are excluded at the beginning of the research. After the selection, the participants were randomly assigned to the experimental and control groups using lottery cards, so that the results of their allocation to the groups were accessible only after the completion of the initial evaluations by the research staff. As a single-blinded study Participants were blinded to grouping and assignments.The inclusion criteria included all patients with blisters due to bone fracture, aged between 18–65, and Consent to participate in the study.The exclusion criteria included Sensitivity to silver, Amputation indication, patients who did not agree to participate in the study, and those who did not participate in the study until the end and did not come for follow-up sessions.The patients were fully informed about the risks, advantages, and trial process. The informed consent was taken from those patients who met the following requirements. They had been diagnosed after the first admission to the Kashani Hospital. They were aged between 18 and 65 years with non-healing blisters that had been created due to bone fracture. All blisters were located on the leg and foot; finally, the patients read, comprehended, and signed the informed consent specific to the study.Neither the therapist and analyst nor the patient know about the treatment and control group. A third person who did not know about the research and the type of treatments simply randomized the patients into 2 groups; in group A, they were treated with Agi Coat dressing and in group B, they were treated with Gaz Vaseline for coating the blister. Agi coat dressing, which was used in this study, was produced by Emad Pharmaceutical Company, Razi industrial zone, Isfahan, Iran.Code and technical specifications of AGICOAT medical dressing pad:
This dressing is a single-layer dressing with a coating of silver nanocrystals, which are coated by the chemical reduction method, silver on a network of nylon fibers with very high flexibility. This layer exerts its antimicrobial and anti-inflammatory effects by slowly releasing silver ions.The blisters were also divided into Hemorrhagic and non-hemorrhagic groups. | PMC10148518 |
How to use the dressing | The wound or burn site was cleaned with distilled water, betadine, burn ointment, etc. The dressing was removed from the package and moistened with distilled water. The excess water was taken from the dressing and placed directly on the wound so that the side was placed at least one centimeter outside the wound. Then another absorbent dressing was placed on the back and finally, it was fixed at the wound site with a simple bandage, tape, or glue. | PMC10148518 | ||
Evaluation of blisters | blisters, pain | LENS | The blisters are all superficial) All blisters are drained during the operation (and the width was measured by ruler next to the blister (Fig. macroscopic view of the blisters and healing process based on dressing type. (The blisters were dressed by Agi coat once a week and every day with Gaz Vaseline, and were followed up in day 7 and 14. On all days of hospitalization and clinic visits in both groups, an orthopedic surgeon and a wound specialist visited the patients. The amount of pain, duration of visit (measured by minutes) and general condition of the wound was checked. Photography was done on the first, seventh and fourteenth days after the first day of dressing. Photographs were taken on all days for all patients by one photographic camera, lens perpendicular to the wound and at a distance of fifteen centimeters from the wound. The pictures of wounds were analyzed by a medical doctor with both Mosaic and image j (fiji) soft ward [ | PMC10148518 |
Result | fracture | From 2020 to 2021, 40 patients with skin blister due to bone fracture entered to study. Data obtained from 31 patients were analyzed after applying the exclusion criteria. The participants were randomly assigned to two. Ag coat groups with 16 participants and Gaz Vaseline group with 15 participants. Table Determining and comparing the demographic characteristics of the participants according to the study groupsTable In Table Determining and comparing the frequency of variablesHemorragicN(%)In macroscopic study and analysis for evaluation and comparing wound area with the Mosaic soft ward, there were significant relation in time (p1 = 0.00). There is no significant difference between the groups (p2 = 0.84). There was significant difference between time and group (p3 = 0.00). In day 14 the wound area between groups had significant difference (p4 = 0.00) (Table Summary of analysis of repeated variance for the average of wound size in treated and control groupP1, P2 and P3 based on repeated measure ANOVA and P4 based on sample T-test, all variables are presented as mean ± SD | PMC10148518 | |
Discussion | blisters, infection, inflammation, pain | INFECTION, WOUND INFECTION, INFLAMMATION | In this study, the patients which their blisters dressed with ag coat dressing had significantly less pain during the time and between groups in compaire with gaz vaselin group, which was mesured by VAS score. Also, in ag coat group the wound healing was significantly faster during the time and in the presence of both groups, which was mesured by analyzed the wound area with the Mosaic soft ward. Duration of visit and the usage of number of dressing was significantly less in ag coat group in compare with gaz vaselin group.A comprehensive systematic review and meta-analysis shows that the use of nanocrystalline silver dressings reduces the length of hospital stay, reduces pain, requires less surgery, and reduces the rate of infection compared to another kinds of dressing [In another study, similar to our study, the rate of healing and pain with silver nanocrystal dressing (single-layer dressing) with a coating of silver nanocrystals by chemical reduction method, silver on a network of nylon fibers with the flexibility of this layer with release Slowly silver ions [Two types of burn wound treatment were compared by Mirza Aghazadeh-Attari et al. Silver nanocrystals are a more effective, less costly option for wound healing than silver sulfadiazine ointment. Studies have shown that infection, healing time, pain, need for skin grafts, and hospitalization duration are all lower with silver nanocrystals. Therefore, studies recommended switching to silver nanocrystals for burn wound healing. Exactly similar to our study, this study showed that silver nylon wound dressing reduces the length of hospital stay, analgesia, wound infection, and inflammation compared to another kind of dressing [In the study of Adhya et al., The healing of burn wounds with silver nanocrystals was faster than other dressing, which showed an increase in the healing effect of silver compounds using nanoparticles [The mentioned studies and other studies in this field have examined the antimicrobial properties of Agicoat silver Nano-Crystalline Dressing due to its properties such as induction of tissue granulation, increased epithelization, increased activity of keratinocytes, reduced inflammation, and reduced pain, and in order to its cost-effectiveness, it is recommended for any casualty [ | PMC10148518 |
Acknowledgements | We would like to thank the colleagues and personnel of the Orthopedic Department and archive staff of Kashani hospital for their valuable technical help and general support. | PMC10148518 | ||
Authors’ contributions | Conception and Design: Mehdi Teimouri and Sahar sadat Lalehzar; Data collection: Mehdi Teimouri, Sahar sadat Lalehzar. Data analysis and interpretation: Sahar sadat Lalehzar, Mehdi Teimouri; Writing the original draft: Mehdi Teimouri, Sahar sadat Lalehzar. All authors approved the final version of the manuscript prior to submission. AND have agreed to be personally accountable for the author's own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. | PMC10148518 | ||
Funding | The project was supported financially by the Isfahan University of Medical Sciences for the design of the study and collection, analysis, and interpretation of data (Research project Number: IR.MUI.MED.REC.1401.025). | PMC10148518 | ||
Availability of data and materials | fracture | The datasets generated and/or analyzed during the current study are not publicly available due to the nature of patients with humeral shaft fracture but are available from the corresponding author on reasonable request. | PMC10148518 | |
Declarations | PMC10148518 | |||
Ethics approval and consent to participate | This research has been performed in accordance with the Declaration of Helsinki and has been approved by the ethics committee of Isfahan University of Medical Sciences (Ethics code: IR.MUI.MED.REC.1401.025 and Iranian Registry of Clinical Trials (IRCT) code: IRCT20221207056744N1). Written informed consent was obtained from the patients. | PMC10148518 | ||
Consent for publication | Not applicable. | PMC10148518 | ||
Competing interests | The authors declared there is no conflict of interest. | PMC10148518 | ||
References | PMC10148518 | |||
Background | PCOS, hirsutism | HIRSUTISM, SECONDARY, POLYCYSTIC OVARY SYNDROME (PCOS), METABOLIC DISORDERS | Considering the high prevalence of polycystic ovary syndrome (PCOS) in women of reproductive age and the metabolic disorders associated with it, this study was conducted to determine the effects of curcumin on metabolic indices and androgen level (primary outcomes), and menstruation characteristics, and hirsutism (secondary outcomes) in women with PCOS. | PMC9930238 |
Methods | PCOS, hirsutism | BLOOD, HIRSUTISM | This triple-blind randomized controlled trial was conducted on women with PCOS who visited the health centers at Eslamshahr County (Tehran Province-Iran) from 2020 to 2022. The participants were allocated into two groups (curcumin and placebo) using block randomization method. The treatment group received two 500 mg edible curcumin tablets together at the same time per day for twelve weeks while the control group received placebo tablets similar to curcumin. Biochemical parameters such as Fasting Blood Insulin (FBI), Fasting Blood Sugar (FBS), triglyceride, total cholesterol, Low Density Lipoprotein- cholesterol (LDL-C), High Density Lipoprotein- cholesterol (HDL-C) were measured before intervention and then 3 months after the intervention. Sex Hormone Binding Globulin (SHBG) and testosterone serum levels were measured 3 months after the intervention. Questionnaires regarding the menstrual cycle characteristics and the Ferriman–Gallwey score were also filled for evaluating hirsutism before the intervention as well as 3 months after the intervention. The independent t-test, Mann-Whitney U test, and ANCOVA were used to analyze the data. | PMC9930238 |
Results | hirsutism, oligomenorrhea, amenorrhea | OLIGOMENORRHEA, HIRSUTISM | There was no statistically significant difference between the two groups in terms of socio-demographic and the baseline levels of measured outcomes. After 12 weeks of intervention, the mean serum FBS levels in the curcumin group were significantly lower than in the placebo group (mean difference: 6.24; 95%confidence interval: -11.73 to -0.76; P = 0.027) but there was no significant difference between the two groups in terms of triglyceride (P = 0.351), cholesterol (P = 0.528), LDL (P = 0.064), HDL (P = 0.306), FBI (p = 0.929), SHBG (p = 0.682), and testosterone (p = 0.133) serum levels. After the intervention, amenorrhea and oligomenorrhea frequency in the curcumin group was significantly lower than in the placebo group (13% vs. 22%, P = 0.038). There was no significant difference in terms of duration of menstruation (P = 0.286) and hirsutism (P = 0.630) between the two groups. | PMC9930238 |
Conclusion | hirsutism, PCOS, amenorrhea | OLIGOMENORRHEA, HIRSUTISM | Curcumin decreased FBS levels and improved menstruation characteristics (amenorrhea, oligomenorrhea, and menstrual irregularities) in women with PCOS but did not affect other metabolic, hormonal, and hirsutism indices. More studies using a larger sample size are required for a definitive conclusion. | PMC9930238 |
Trial registration | Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N51 Date of registration: 30/11/2019. URL: | PMC9930238 | ||
Keywords | PMC9930238 | |||
Background | obesity, PCOS, infertility, intrauterine factors, acne, hirsutism, metabolic syndrome | OBESITY, COMPLICATIONS, METABOLIC SYNDROME, MENSTRUAL DISORDERS, INSULIN RESISTANCE, ACNE, HIRSUTISM, POLYCYSTIC OVARY SYNDROME, PATHOGENESIS, INSULIN RESISTANCE SYNDROME | Polycystic ovary syndrome (PCOS), also known as metabolic syndrome or insulin resistance syndrome [Many of the systems in the body are affected by PCOS which leads to several complications such as menstrual disorders, infertility, hirsutism, acne, obesity and metabolic syndrome [PCOS pathogenesis are still unknown but studies show that PCOS has a complicated and multi-factor cause that stems from the interaction of genetic, environmental, and intrauterine factors [Curcumin is a polyphenol derived from the curcuma longa species and traditionally can be found in Asian food [As seen in animal experiments, the use of curcumin can lead to a decrease in insulin resistance (one of the key features of PCOS phenotype), a decrease in blood’s inflammatory factors such as CRP and IL-6 [ | PMC9930238 |
Methods | PMC9930238 | |||
Study design and setting | This study was a superiority randomized controlled trial with two-parallel arms. The participants, researcher, and analyst in this study were blinded to the intervention received by the participants. This study was conducted in the health centers at Eslamshahr County (Tehran Province-Iran) from 2020 to 2022. | PMC9930238 | ||
Eligibility criteria | PCOS, metabolic diseases, CAH, androgenic disorders, diabetes | CAH, METABOLIC DISEASES, CUSHING SYNDROME, THYROID GLAND DISEASES, DIABETES | The study was conducted on women aged 18 to 45 with PCOS and a BMI of 18.5 to 40. The exclusion criteria were as follows: taking vitamins, contraceptives, hormonal drugs, minerals, and omega-3 during the study and 3 months before intervention; having other metabolic diseases such as diabetes and androgenic disorders such as congenital adrenal hyperplasia (CAH) or androgen-producing glands; thyroid gland diseases; Cushing syndrome; pregnancy or breastfeeding; prior surgery on one or both ovaries; smoking and alcohol consumption. | PMC9930238 |
Sampling | oligomenorrhea, PCOS, hirsutism | BLOOD, INSULIN RESISTANCE, OLIGOMENORRHEA, HIRSUTISM | Sampling started after the approval of the ethics committee of Tabriz University of Medical Sciences (Ethics code: IR.TBZMED.REC.1398.017) and registering the study in Iranian Registry of Clinical Trials (IRCT) (Code: IRCT20120718010324N51). The researcher attended at the health centers in the Eslamshahr city and searched for women with eligible criteria and willingness to participate in the study. They were surveyed based on Rotterdam criteria (the presence of two of the three criteria is enough to diagnose PCOS) which include oligomenorrhea (i.e., a menstrual cycle that lasts more than 35 days or having four to nine cycles each year) [After PCOS was confirmed, written consent is obtained in case of the patient’s willingness to participate in the study and questionnaires regarding socio-demographic and menstrual cycle characteristics were completed. A food consumption frequency questionnaire was also provided to the participants to record their average annual food consumption. The hirsutism score of the participants was determined by the researcher using Ferriman-Gallwey criteria as well as their weight and height to determine their BMI before intervention were measured. A checklist was given to the participants to remind them of their daily medication use, and they were contacted monthly to ensure that they were taking the medication.The participants’ biochemical parameters including Fasting Blood Insulin (FBI), Fasting Blood Sugar (FBS), triglyceride, total cholesterol, LDL-C, HDL-C were measured before intervention and then 3 months after. The participants were directed to Ava laboratory in Eslamshahr for those measurements. Venous sampling was used with a 5 ml syringe by the laboratory personnel to extract 5 ml of blood from the brachial region. The test results were provided to the researcher. Three months after the intervention, hormonal tests (testosterone and SHBG) were measured as well. All blood tests were conducted at a certain stage of the menstrual cycle (follicular phase). Insulin resistance index (HOMA-IR) was calculated based on FBS and FBI. The participants were to refrain from using hormonal drugs, and supplements, having specific diets or doing heavy sports during the study. | PMC9930238 |
Random allocation & intervention | The participants were allocated into two groups (curcumin and placebo) using block randomization with a ratio of 1:1. Identical black opaque bottles numbered consecutively (in order of allocation) were used to conceal what was allocated to each participant. The bottles were prepared by a third party that had no role in the sampling or gathering and analysis of data. The curcumin and placebo were produced by Dineh Iran pharmaceutical company (Qazvin, Iran). The intervention group received two 500 mg tablets of edible curcumin together at the same time per day for twelve weeks while the control group received placebo tablets similar to curcumin. Placebo and curcumin tablets were identical in terms of weight, shape, color and smell. | PMC9930238 | ||
Data collection tools | bleeding, hirsutism | BLEEDING, EXCESSIVE HAIR GROWTH, HIRSUTISM | Questionnaires for socio-demographic information, a checklist for recording tests, a menstrual cycle characteristics questionnaire, and the Ferriman–Gallwey scale were used to collect the data. The food frequency questionnaire (FFQ) was used to measure the nutritional status of the participants.The menstrual cycle characteristics questionnaire includes questions about the average interval of menstrual cycles and the average duration of bleeding in the last three months which are asked twice, once at the beginning of the study and then three months after the intervention.The Ferriman–Gallwey scale is also used in the same two time periods to evaluate hirsutism. This scale evaluates the state of hair growth in 9 areas of the body and assigns a score between zero and four according to the Likert scale. Zero means no hair and four means excessive hair growth. The highest possible score for any one participant in this questionnaire would be 36 and the lowest score would be zero [The FFQ used in this study included 67 types of food which were used to gather information about the intake of each food. The participants were asked about the frequency and amount of intake of each food during a day, week, and month. The data was eventually summarized into “how many times in the week the participant ate each type of food”, “how many grams of it was eaten each time”, and “how many grams of it was eaten each week”.To assess adherence to treatment, the participants were requested to record the drug use in a drug use checklist. | PMC9930238 |
Sample size | The sample size was determined based on the testosterone levels using G*Power software. Considering the data from the Gholizadeh Shamasbi study [ | PMC9930238 | ||
Statistical analysis | hirsutism | HIRSUTISM | After gathering the data, SPSS software version 24 was used for data analysis. Descriptive statistics such as mean (standard deviation) were used for quantitative data and number (percentage) was used for qualitative data. Median (percentile 25 to percentile 75) was used for quantitative data that had an abnormal distribution. Kolmogorov-Smirnov test was used to evaluate the normality of the data. Variables such as fasting insulin and HOMA-IR before and after intervention, testosterone, SHBG, hirsutism before and after intervention, and the duration of menstruation had an abnormal distribution while other variables had a normal distribution. An independent t-test was used for an intergroup comparison of variables with a normal distribution before intervention and after the intervention, ANCOVA test was used with a control of baseline values. Mann-Whitney U test was used for an intergroup comparison of variables with an abnormal distribution before and after the intervention. The paired samples t-test and Wilcoxon signed ranks test were used for intra-group comparisons of outcomes with normal and abnormal distribution, respectively.To analyze the FFQ, the nutrient units were converted to grams per day using the book “The Manual for Household Measures”. Also, any food or drink was coded and recorded in Nutritionist IV software which was adjusted for Iranian food to evaluate the amount of energy and nutrients received by the participants. The intake of energy, macronutrients, and micronutrients of each participant was also determined. All of the analysis was done base on an intention to treat. P < 0.05 was considered as significant. | PMC9930238 |
Results | Between 2019 and 2022 about 100 people were evaluated in terms of having the necessary criteria. Four did not enter the study for lack of interest, 15 for having a certain diet, and 27 for having used contraceptives recently. In the end, the data from 27 people in the intervention group and 27 people in the control group were analyzed (Fig.
Study flow chartThe average age of women in the curcumin group was 28.44 (SD: 7.61) years while the average age of women in the placebo group was 30.85 (SD: 8.63) years. The BMI score of the curcumin group was 27.34 (SD: 5.42) kg/m
Socio-demographic characteristics and nutritional values by study groups* Standard Deviation; | PMC9930238 | ||
Primary outcomes | The mean (SD) serum FBS level before intervention was 93.92 (9.12) in the curcumin group and 91.33 (9.40) in the placebo group so there was no statistically significant difference between the two groups (P = 0.314). After 12 weeks of intervention, the mean (SD) serum FBS level in the curcumin group was 90.38 (10.69) and in the placebo group it was 95.22 (11.22) which is significantly higher than the curcumin group (Mean Difference (MD): -6.24; 95% Confidence Interval (95% CI): -11.73 to -0.76; P = 0.027).The mean (SD) serum triglyceride level before intervention was 110.81 (47.11) in the curcumin group and 137.19 (43.20) in the placebo group which means a statistically significant difference between the two groups (P = 0.038). After 12 weeks of intervention, the mean (SD) serum triglyceride level in the curcumin group was 128.02 (6.13) and in the placebo group it was 136.27 (6.00) which means no statistically significant difference between the two groups (MD: -8.25; 95% CI: -25.85 to 9.35; P = 0.351).The mean (SD) serum cholesterol level before intervention was 158.46 (32.9) in the curcumin group and 162.59 (34.97) in the placebo group so there was no statistically significant difference between the two groups (P = 0.660). After 12 weeks of intervention, the mean (SD) serum cholesterol level in the curcumin group was 165.85 (37.69) and in the placebo group it was 174.19 (40.93) which means no statistically significant difference between the two groups (MD: -6.25; 95% CI: -26.13 to 13.57; P = 0.528).The mean (SD) serum LDL level before intervention was 88.77 (25.33) in the curcumin group and 91.11 (27.99) in the placebo group so there was no statistically significant difference between the two groups (P = 0.751). After 12 weeks of intervention, the mean (SD) serum LDL level in the curcumin group was 89.96 (30.92) and in the placebo group it was 105.70 (29.33) which means no statistically significant difference between the two groups (MD: -14.81; 95% CI: -30.52 to 0.91; P = 0.064).The mean (SD) serum HDL level before intervention was 50.12 (10.89) in the curcumin group and 105.70 (29.33) in the placebo group so there was no statistically significant difference between the two groups (P = 0.614). After 12 weeks of intervention, the mean (SD) serum HDL level in the curcumin group was 53.77 (13.15) and in the placebo group it was 51.56 (9.74) which means no statistically significant difference between the two groups (MD: 3.22; 95% CI: -3.04 to 9.48; P = 0.306).The mean (SD) serum fasting insulin level before intervention was 12.54 (7.56) in the curcumin group and 9.76 (7.25) in the placebo group so there was no statistically significant difference between the two groups (P = 0.135). After 12 weeks of intervention, the mean (SD) serum fasting insulin level in the curcumin group was 9.50 (7.02) and in the placebo group it was 10.11 (9.30) which means no statistically significant difference between the two groups (P = 0.929).The mean (SD) HOMA-IR before intervention was 2.88 (1.99) in the curcumin group and 2.16 (1.43) in the placebo group so there was no statistically significant difference between the two groups (P = 0.229). After 12 weeks of intervention, the mean (SD) serum HOMA-IR in the curcumin group was 2.11 (1.79) and in the placebo group it was 2.40 (2.11) which means no statistically significant difference between the two groups (P = 0.736).After the intervention, the mean (SD) serum testosterone level in the curcumin group was 0.64 (0.39) and in the placebo group it was 0.77 (0.36) which means no statistically significant difference between the two groups (0.133). After the intervention, the mean (SD) serum SHBG level in the curcumin group was 57.11 (38.57) and in the placebo group it was 60.67 (40.87) which means no statistically significant difference between the two groups (P = 0.682).The intra-group comparison results showed that there was statistical significant difference between before and after intervention in terms of fasting insulin level (P = 0.005) and HOMA-IR (P = 0.005) in the curcumin group. Also, the post-intervention FBS level increased significantly compared to pre-intervention level in the placebo group (P = 0.037) (Table
Comparison of the metabolic indices levels by study groups* Standard Deviation; | PMC9930238 | ||
Discussion | hirsutism, oligomenorrhea, PCOS, amenorrhea | INSULIN RESISTANCE, OLIGOMENORRHEA, HIRSUTISM | According to the study results, administrating curcumin only led to a decrease in FBS levels and did not significantly affect other metabolic indices (triglyceride, cholesterol, LDL-C, HDL-C, insulin, testosterone and SHBG). Regarding the amenorrhea and oligomenorrhea frequency, the numbers in the curcumin group were significantly lower than in the placebo group but there was no statistically significant difference between the two groups in terms of length of menstruation. Also, curcumin had no significant positive effect on hirsutism in women with PCOS.In the present study, administrating curcumin led to a decrease in FBS, FBI and HOMA-IR in the curcumin group. Our results were partly consistent with those of previous studies; in a randomized clinical trial, 60 individuals with PCOS were randomly divided into a curcumin and placebo groups and received 500 mg of curcumin or placebo tablets for 12 weeks. Generally administrating curcumin for 12 weeks to women with PCOS had positive effects on body weight, controlling the blood sugar, serum lipids (except triglycerides), very low-density lipoprotein (VLDL-cholesterol) levels, and peroxisome proliferator-activated receptor gamma (PAR-g) and low-density lipoprotein receptor (LDLR) gene expression [In a systematic review, the effect of curcumin on glycemic control and lipid profile was examined. Based on the result of the reviewed studies, curcumin improved fasting glucose levels, insulin, and homeostasis model assessment of insulin resistance (HOMA-IR) in a significant way. Moreover, high-density lipoprotein and cholesterol levels were significantly improved. But it did not have any significant effect on improving low-density lipoprotein and triglyceride levels [Curcumin decreases blood sugar through different mechanisms such as increasing glucose and glycolysis uptake and glycogen synthesis in skeletal muscles or decreasing gluconeogenesis in the liver [Probably, the anti-inflammatory property of curcumin is also effective in regulating glucose and lipid metabolism. As pro-inflammatory cytokines is higher in patients with PCOS [Also, it seems that curcumin affects glucose metabolism by causing changes in enzyme activity associated with glucose; curcumin increases hepatic glucokinase activity while significantly decreasing glucose 6-phosphate and phosphoenolpyruvate carboxykinase activities. Curcumin stimulates the release of glucagon-like peptide-1 [Following all principles of a clinical trial such as random allocation, hiding allocation, and blinding were among the strengths of this study. No loss of samples was another strength of this study. The small sample size was one of the limitations of this study and having a bigger sample size is recommended for further studies. Also, the study power was lower than 80% for detecting of significant difference between groups for testosterone level outcome. | PMC9930238 |
Acknowledgements | We sincerely thank all women who participated in this study. Also, we thank Dineh Iran pharmaceutical company for supplying the curcumin and placebo tablets. | PMC9930238 | ||
Funding | NG and MM were responsible for drafting the trial protocol, data collection, data analysis and interpretation and writing of the final report. SG, ES and SA were involved in drafting the protocol, data collection and approved the final version of the manuscript.This research is supported by Tabriz University of Medical Sciences. The funding source had no involvement in design of the study, data collection, data analysis, etc. | PMC9930238 | ||
Declarations | The datasets generated and/or analysed during the current study are not publicly available due to limitations of ethical approval involving the patient data and anonymity but are available from the corresponding author on reasonable request. | PMC9930238 | ||
Ethics approval and consent to participate | This study was approved by the Ethics committee of Tabriz University of Medical Sciences with the code of IR.TBZMED.REC.1398.017. All participants were ensured about the matter of confidentiality. Also, informed written consent was obtained from all participants and parent/legally authorized representatives of illiterate participants. All methods were performed in accordance with the Declaration of Helsinki. | PMC9930238 | ||
Consent for publication | Not applicable. | PMC9930238 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9930238 | ||
References | BLOOD, INSULIN RESISTANCE | Fasting Blood InsulinFasting Blood SugarLow Density Lipoprotein- cholesterolHigh Density Lipoprotein- cholesterolSex Hormone Binding GlobulinIranian Registry of Clinical TrialsPolycystic ovary syndromedehydroepiandrosterone sulfateCongenital Adrenal HyperplasiaFood Frequency QuestionnaireStandard DeviationMean Difference95% Confidence IntervalAMP-activated protein kinaseMitogen-Activated Protein KinaseHomeostatic Model Assessment for Insulin Resistance. | PMC9930238 | |
Methods | A total of 21 preoperative CPETs were interpreted by two exercise physiologists using stationary time-based data-averaging intervals of 10, 20, and 30 seconds and rolling average intervals of 3 and 7 breaths. Mean values of CPET variables between different data averaging intervals were compared using repeated measures ANOVA. The variables of interest were oxygen uptake at peak exercise (VO | PMC10019694 | ||
Results | Between data-averaging intervals, no statistically significant differences were found in the mean values of CPET variables except for the ventilatory equivalent for carbon dioxide at the ventilatory anaerobic threshold (P = 0.001). No statistically significant differences were found in the proportion of patients classified as high or low risk regardless of the used data-averaging interval. | PMC10019694 | ||
Conclusion | There appears to be no significant or clinically relevant influence of the evaluated data-averaging intervals on the mean values of CPET outcomes used for preoperative risk assessment. Clinicians may choose a data-averaging interval that is appropriate for optimal interpretation and data visualization of the preoperative CPET. Nevertheless, caution should be taken as the chosen data-averaging interval might lead to substantial within-patient variation for individual patients. | PMC10019694 | ||
Clinical trial registration | Prospectively registered at ClinicalTrials.gov ( | PMC10019694 | ||
Data Availability | All relevant data are within the paper and its | PMC10019694 | ||
Introduction | POSTOPERATIVE COMPLICATIONS | Preoperative aerobic fitness is independently associated with postoperative outcomes following major abdominal surgery [During CPET, a patient exercises against a progressively increasing work rate until volitional exhaustion, while breath-by-breath respiratory gasses are analyzed. The large number of data-points that are collected by the breath-by-breath sampling rate can be a challenge for data visualization, as the signal can have high variability. Therefore, data-averaging is performed to optimize graphical data display and to aid CPET interpretation (see Visualization of the plot with oxygen uptake (VOThe most frequently used CPET-derived variables that are associated with postoperative complications in the current literature are the oxygen uptake at peak exercise (VOAlthough preoperative risk assessment should be multimodal, CPET-derived thresholds are often used to recognize patients with a low aerobic fitness who have a high risk for adverse surgical outcomes. In major abdominal surgery, often used thresholds to identify patients at high-risk for postoperative complications are a VO2peak <18.2 mL/kg/min and/or a VO2VAT <11.1 mL/kg/min [ | PMC10019694 | |
Methods | SECONDARY | This observational cross-sectional study was performed at the VieCuri Medical Center, a large teaching hospital in Venlo, the Netherlands. The current study was executed as a secondary analysis of data collected in a study [ | PMC10019694 | |
Participants | colorectal cancer | COLORECTAL CANCER | Data from consecutive patients considered for colorectal cancer surgery who were ≥18 years of age, had a score ≤7 metabolic equivalents of task on the veterans-specific activity questionnaire, and therefore performed preoperative CPET as a part of a tele-prehabilitation study [ | PMC10019694 |
Preoperative cardiopulmonary exercise testing | Patients preoperatively performed incremental CPET up to volitional exertion in upright position on an electronically-braked cycle ergometer (Lode Corival, Lode BV, Groningen, the Netherlands). Prior to the test, patients were asked to refrain from vigorous physical activity, caffeine, and tobacco for 24 hours and meals for 2 hours, but to continue medication as usual. Seat height was adjusted to the participant’s leg length. Before commencing CPET, forced vital capacity and forced expiratory volume in one second was obtained from maximal flow-volume curves (Ergostik, Geratherm Respiratory, Bad Kissingen, Germany) according to ATS/ERS standards [During CPET, subjects breathed through a facemask (Hans Rudolph, Kansas City, MO, USA) connected to an ergospirometry system (Ergostik, Geratherm Respiratory, Bad Kissingen, Germany). Before every test, calibration for respiratory gas analysis measurements (ambient air and a gas mixture of 16% oxygen and 5% carbon dioxide) and volume measurements (three-liter syringe) took place. Expired gas passed through a flow meter (triple V volume transducer), an oxygen analyzer, and a carbon dioxide analyzer. The flow meter and gas analyzers were connected to a computer that calculated breath-by-breath minute ventilation, oxygen uptake, carbon dioxide production, and the respiratory exchange ratio. Raw unfiltered breath-by-breath data was retrogradely averaged over five different data display intervals. | PMC10019694 | ||
Procedures | comorbidity, tumor | TUMOR | Preoperative CPET patient data was anonymized and patient characteristics other than anthropometric measures were concealed. A medical and clinical exercise physiologist (BB) and a clinical exercise physiologist (RF) determined VOApart from the CPET data, the preoperative patient characteristics age, sex, body mass index, smoking status (never, former, current), age-adjusted Charlson comorbidity index, American Society of Anesthesiologists classification, veterans-specific activity questionnaire score, hemoglobin levels (mmol/L), and tumor location were recorded to characterize the study population. | PMC10019694 |
Sample size | A sample size calculation was performed with G*Power [ | PMC10019694 | ||
Statistical analysis | Continuous data were checked for normality using the Shapiro-Wilks test. To assess the difference between different CPET data-averaging intervals, differences in mean numerical values of VO | PMC10019694 | ||
Results | colorectal cancer | COLORECTAL CANCER | A total of 21 CPETs of patients with colorectal cancer (see | PMC10019694 |
Baseline characteristics of subjects. | Data are presented as mean ± standard deviation (SD) or as number (%).Mean values of the CPET-derived variables ranged from 14.5 mL/kg/min to 14.6 mL/kg/min for VO | PMC10019694 | ||
Discussion | colorectal cancer, CRF | COLORECTAL CANCER, CRF, SECONDARY, POSTOPERATIVE COMPLICATIONS | To our knowledge, the current study was the first study that aimed to investigate whether the selection of different CPET data-averaging intervals would translate into differences in mean values of CPET-derived variables in patients with colorectal cancer who performed CPET for preoperative risk assessment. As CPET-derived variables are used to preoperatively classify patients into having a low or high risk for postoperative complications based on their CRF, the secondary aim of the current study was to investigate whether potential differences in the numerical values of CPET-derived variables would lead to differences in preoperative risk classification. Based on the mean values of the CPET-derived variables there were only statistically significant differences for the variables VOFor VOThe main purpose of using data-averaging of CPET data is to reduce noise of breath-by-breath fluctuations and to aid CPET interpretation [Although the literature is scarce with regard to the influence of data-averaging intervals on the determination of CPET-derived variables (and only available for VOBased on the results of this study, the recommendation in the preoperative CPET guideline to use a breath-based data-averaging interval of 3–5 breaths or a time-based data-averaging interval of ~20 seconds seems plausible when evaluating the mean (group level) values. Nevertheless, caution should be taken when evaluating individual patients, as different data-averaging intervals caused substantial variation in the numerical values of CPET-derived variables within patients. As depicted in A limitation of the current study was that VOThe current study opens possibilities for clinicians to be flexible in the data-averaging interval that is used for interpretation of the preoperative CPET. Current CPET literature does not provide clear and consistent guidance for clinicians about the choice of a data-averaging interval [ | PMC10019694 |
Conclusion | On a group level there appear to be no clinically relevant differences in the mean values of VO | PMC10019694 | ||
Supporting information | PMC10019694 | |||
Graphical display of the Wasserman plots of patient 21. | (PDF)Click here for additional data file. | PMC10019694 | ||
Guideline for systematic interpretation of preoperative cardiopulmonary exercise testing. | (PDF)Click here for additional data file.(XLSX)Click here for additional data file.The authors like to thank Accuramed BVBA (Halen, Belgium) for providing a free unrestricted copy of the Blue Cherry software to support this study. | PMC10019694 | ||
Objective | POSTOPERATIVE COMPLICATIONS | Hepatobiliary surgery bares obstacles to informed consent for the patients due to its complexity and related risk of postoperative complications. 3D visualization of the liver has been proven to facilitate comprehension of the spatial relationship between anatomical structures and to assist in clinical decision-making. Our objective is to utilize individual 3D-printed liver models to enhance patient satisfaction with surgical education in hepatobiliary surgery. | PMC9970129 | |
Design, setting | THORACIC | We conducted a prospective, randomized pilot study comparing 3D liver model-enhanced (3D-LiMo) surgical education against regular patient education during preoperative consultation at the department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden, Germany. | PMC9970129 | |
Participants | Of 97 screened patients, undergoing hepatobiliary surgery, 40 patients were enrolled from July 2020 to January 2022. | PMC9970129 | ||
Results | The study population ( | PMC9970129 | ||
Conclusion | MINOR, POSTOPERATIVE COMPLICATIONS | In conclusion, individual 3D-printed liver models increase patient satisfaction with surgical education and facilitate patients’ understanding of the surgical procedure as well as awareness of postoperative complications. Therefore, the study protocol is feasible to apply to an adequately powered, multicenter, randomized clinical trial with minor modifications. | PMC9970129 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00464-023-09915-w. | PMC9970129 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL.Liver surgery is one of the most technically challenging procedures in the field of abdominal surgery due to the complex intrahepatic anatomy of the vasculature and biliary tree with frequent variations. In the last decades, advancements in perioperative patient care have increased the safety of liver resections [3D visualization has gained broad applications in preoperative planning and intraoperative navigation particularly in hepatobiliary surgery [While the educational benefit of 3D visualization in the clinical setting for the operating surgeons- especially young surgeons has been explored previously [ | PMC9970129 | ||
Material and methods | PMC9970129 | |||
Study design | This study was designed as a prospective, non-blinded, randomized controlled, monocentric pilot trial [Flow diagram of the study protocol including time points of scheduled patient visitations, generation of the 3D liver models and data acquisition | PMC9970129 | ||
Patient population | cognitive impairment | 97 patients, presenting in the outpatient clinic of the Surgery Department in the University Hospital Dresden for liver surgery between July 2020 and January 2022, were screened for inclusion. Inclusion criteria implied age above 18 years, indication for liver resection and preoperative CT imaging. In addition, a 2 weeks minimum time gap between enrollment and preoperative consultation was required for manufacturing of the 3D-printed models. A language barrier, lack of compliance or cognitive impairment were considered exclusion criteria. | PMC9970129 | |
Study endpoints | postoperative blood transfusions | The primary endpoint of this study was patient satisfaction with surgical education. Secondary endpoints included understanding of the planned surgery, surgery length, conversion to open surgery, postoperative blood transfusions, postoperative morbidity and mortality, need of surgical revision, postoperative interventions, postoperative length of intensive care unit (ICU) stay and postoperative length of hospital stay. | PMC9970129 | |
Statistics | The Kolmogorov–Smirnov test was used to assess distribution of investigated parameters. Categorical and quantitative variables were analyzed using Fisher’s exact test and unpaired t-test, respectively. Data was expressed as mean±standard deviation. Numeric variables were expressed as median with interquartile range (IQR). The values | PMC9970129 | ||
Ethical aspects and trial registration | The study was conducted according to the Declaration of Helsinki with waivers of informed consent of all patients. Ethical approval by local ethics committee was obtained before analysis (Number: BO-EK-168052020). The current study was registered at the German Clinical Trials Register (Deutsches Register Klinische Studien (DRKS)) with the number DRKS00022397. | PMC9970129 | ||
Results | PMC9970129 | |||
Patients’ satisfaction with surgical education and perception of the 3D liver model. | Immediately after surgical and anesthesiological education, patient’s satisfaction was inquired via questionnaire. No significant differences were observed with satisfaction with overall medical care, medical care by surgeons or nurses, surgical preparations in general and anesthesiological preparations (Table Preoperative patient questionnaire | PMC9970129 | ||
Patient’s apprehension of the underlying disease and planned surgery | We evaluated patient’s understanding of the planned surgical procedure following surgical education. First, patients had to name the surgical procedure in their own words, we saw that most patients referred to unspecific terms (e.g. removal of mass) without clarifying mass count and location or type of resection (52.5%, data not shown). When asked to pick the correct type of liver surgery from a displayed list (atypical resection, anatomic resection, hemi-hepatectomy, associating liver partition and portal vein ligation for staged hepatectomy, left or right lobe), 80% of patients from the 3D-LiMo group and 55% of the control group correctly selected the surgical procedure ( | PMC9970129 | ||
Surgical procedures and postoperative clinical course | intraoperative blood loss | ADVERSE EVENTS, INTRAOPERATIVE BLOOD LOSS, POSTOPERATIVE COMPLICATIONS | The control and 3D-LiMo groups displayed no differences in the length of the operation, intraoperative blood loss and other characteristics of the surgical procedure. Also, none of the patients experienced adverse events during surgery (Table Specification of surgical procedure, postoperative clinical course and postoperative patient questionnaire683.2(821.4)*Complications in the clinical postoperative course occurred in both groups. Nevertheless, no significant differences in the number of postoperative complications between the two groups were observed (45% and 50% of the 3D-LiMo or control group, respectively (Table Postoperative patient satisfaction was assessed on the day of dismissal from the surgical ward. The majority of patients in the control and 3D-LiMo group were visited by the operating surgeon before (70% and 61.1%, respectively) and/ or afterwards (75 and 80%, respectively). Patients in the 3D-LiMo group were significantly more likely to correctly answer, whether postoperative complications have occurred, in comparison to the control group (94.4 vs. 68.4%, respectively, | PMC9970129 |
Follow-up evaluation 4 to 12 weeks after hospital discharge | cancer, death | CANCER, EVENT, RECURRENCE, COMPLICATIONS | No differences in the occasion of complications, recurrence of cancer or death was assessed (Supplementary table 1). First, we assessed that 95% of control population correctly recalled the event of complications in comparison to 67% of patients in the 3D-LiMo group. Second, we evaluated patient’s health awareness and satisfaction at the time of follow-up. 75% of control patients were very satisfied with surgical education in retrospect while only 61% of 3D-LiMo patients classified themselves of that kind. Nevertheless, the rest of 3D-LiMo patients (39%) was still satisfied (Supplementary table 1). | PMC9970129 |
Discussion | tumors | POSTOPERATIVE COMPLICATIONS, DISEASE, RECRUITMENT, TUMORS, COMPLICATIONS | The present study analyzes whether a personalized 3D-printed liver model manifests an educational benefit to patients, encourages their involvement in the decision-making process and thereby enhances patient’s satisfaction. As surgical procedures of the liver have become more complex and are frequently associated with postoperative complications, we applied patient questionnaires to examine the level of surgical comprehension and level of satisfaction with surgical education when 3D liver models were applied in addition to preexisting informational sheets. Overall, patient satisfaction with preoperative preparations was very high in general (Table The current study revealed that surgical education applying 3D models was associated with enhanced disease understanding as 3D-LiMo patients were significantly more likely to correctly point out the number of liver masses (100 vs. 70% in the 3D-LiMo and control groups, respectively; We were not able to detect an effect of the 3D model on patient satisfaction at the end of the hospital stay or at the follow-up appointment. We suggest that satisfaction levels at these time points are more dependent on the medical care at the surgical ward including nurses and physicians, occurrence of complications and the overall success of the surgery. The two study groups did not display a significant difference in morbidity, mortality, length of intensive care unit or total hospital stay.The present study has limitations. First, the pilot trial design of the study leads to a small study population of 40 patients in total. This small number of enrolled patients lowered the likelihood of detecting significant differences. Nevertheless, this study serves as proof of principle for the application of 3D liver visualization during preoperative consultation and the justification of future clinical studies. Second, this study was conducted as a single center experience. Nevertheless, as we aimed to assess educational benefit and satisfaction in patients, we suggest that this limitation did not affect our results and conclusions. Third, the high requirements of the CT scan and time expenditure of generating the 3D-printed models individually for each patient resulted in low recruitment rates. Resource-intensive, patient-specific 3D models pose an additional expenditure to hospitals. Despite this direct increase in financial costs, we suggest that application of 3D models reduce overall costs of hospitalization eventually. Despite our focus on improvement of patient’s literacy of their disease and the planned surgical procedure, we see the advantage of 3D models in their diverse application. Individualized 3D anatomical models of the liver can improve pre-operative planning through enhanced visualization of the specific patient’s liver anatomy and facilitated comprehension of anatomic relation of tumors to the intrahepatic vasculature [ | PMC9970129 |
Conclusion | MINOR, POSTOPERATIVE COMPLICATIONS | In conclusion, individual 3D-printed liver models increase patient satisfaction with surgical education immediately following patient education. Besides this comforting value, liver models implicate an educational benefit for patients and reinforce patients’ engagement in the decision-making process. Patients of the 3D-LiMo group were significantly more likely to correctly state the number and location of liver masses. Enhanced understanding of the surgical procedure in the 3D-LiMo group transferred into a higher awareness of postoperative complications. As a result, the current study protocol is feasible to apply to an adequately powered, multicenter, randomized clinical trial with minor modifications. Based on our finding, we strongly recommend the application of 3D-printed models during patient education whenever available. | PMC9970129 | |
Author contributions | CR: designed the clinical trial. All authors contributed to the study conception. Material preparation, data collection and analysis were performed by CR, SD, EGB, SG and FO. The first draft of the manuscript was written by EGB and CR and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. | PMC9970129 |
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