title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Methods | PMC10210318 | |||
Study patients | T1D | This was a phase 1b, dose-escalation, randomized, placebo-controlled study of IMCY-0098 in patients with recent-onset T1D. Additional information on the conduct of the study can be found in the study protocol (Additional file All participants provided signed informed consent. The study was conducted in accordance with ... | PMC10210318 | |
Study treatment | death, anaphylactic reaction, illness | ANAPHYLACTIC REACTION | Study patients were randomly allocated in a 3:1 ratio to receive IMCY-0098 or placebo. Treatment allocation at each site was performed using central randomization via an Interactive Web Response System.Treatment was injected subcutaneously in the upper arm (midway between the elbow and the shoulder); each dose was divi... | PMC10210318 |
Study procedures and assessments | PMC10210318 | |||
Safety | inflammation/swelling, Itching | INDURATION, BLOOD, INJECTION SITE REACTION | Study visits and procedures are shown in Additional file The intensity of injection site reactions was determined by study center staff for the first four patients of each cohort, either by visual assessment or through questioning the patient, and self-reported by the rest of the patients. Injection site erythema/redne... | PMC10210318 |
Clinical response | Tecan | DISEASE PROGRESSION | Stimulated C-peptide secretion was assessed by the 2-h MMTT method at screening, Week 12, and Week 24. MMTT was performed in fasting patients using Ensure Plus (220 mL; 330 kcal; Abbott Laboratories) as a standardized meal administered between 07:00 h and 10:00 h, with 5 collection time points (before the meal and 30 ±... | PMC10210318 |
Statistical analysis | DISEASE PROGRESSION | The study sample size was determined as adequate to provide a reliable safety assessment of the tested doses and to support the preliminary assessment of clinical response endpoints. The sample size used in this study was aligned with a similar study of peptide immunotherapy which found the safety profile to be as expe... | PMC10210318 | |
Results | PMC10210318 | |||
Study patients | TYPE 1 DIABETES | Of 65 screened patients with recent-onset type 1 diabetes, 41 were randomized to receive placebo (Figure to show the sequential study design (The mean age was 24.0 years, and 31.7% of all participants were women. Mean age, BMI, and time from diagnosis were similar across cohorts; however, there were differences in coho... | PMC10210318 | |
Clinical response | hypoglycemia | HYPOGLYCEMIA, PROGRESSION, TOLERANCE, EVENTS, EVENTS | In the ITT set, clinical response was assessed using the Mixed Meal Tolerance Test (MMTT) and total daily consumption of insulin (both slow- and fast-acting) (Fig. Progression of clinical response measured by AUC C-peptide from MMTT (During the study period, the levels of autoantibodies against GAD65 and ZnT8 decreased... | PMC10210318 |
Long-term follow-up | A total of 30 patients from the ITT population participated in the follow-up to Week 48: placebo (Mean fasting C-peptide was similar between the treatment groups at baseline and no notable changes were observed in any group. The mean (SD) change from baseline to Week 48 was − 0.02 (0.12) nmol/L in the placebo group, 0.... | PMC10210318 | ||
Discussion | T1D | DISEASE PROGRESSION, DISEASE, COMPLICATIONS | Since the discovery of insulin therapy over 100 years ago, there have been no major changes in the clinical management of T1D apart from technical improvements in, for example, insulin variants, continuous glucose monitoring, and insulin pumps. These technologies clearly facilitate the daily control of blood glucose fo... | PMC10210318 |
Conclusions | T1D | This first-in-human study showed that IMCY-0098 has a promising safety profile in patients with recent-onset T1D at all doses tested. The safety profile of IMCY-0098 supports further investigation and risk/benefit optimization for different doses and schedules of this novel treatment. This will be further evaluated in ... | PMC10210318 | |
Acknowledgements | The authors would like to thank the patients and their families, all participating investigators, sites, and site teams. A full list of sites can be found in Additional file | PMC10210318 | ||
Authors’ contributions | LVE, NB | RECRUITMENT | JVR, VC, RRA, EG, NB, LVE, MVM, PV: laboratory analysis; MK, FP: (specialized) statistical analysis; JVR, PA, RDL, MAA, CD, BK, KRO, NB, CB, PV: clinical study concept and design. PA, RDL, MAA, CD, BK, KRO, CB: patient recruitment and treatment. All authors: data analysis and interpretation, critical review of the manu... | PMC10210318 |
Authors' information | Twitter handles: Jean Van Rampelbergh: @JeanRampelbergh; Katherine Owen: @drkathowen. | PMC10210318 | ||
Funding | Imcyse S.A. (Liège, Belgium), EU FP7 program (N°602515), DG06 (Walloon Region, Belgium, N°7873). | PMC10210318 | ||
Availability of data and materials | De-identified patient data can be provided to independent qualified researchers upon submission of a written application/research proposal that should be approved by the study sponsor, Imcyse S.A. | PMC10210318 | ||
Declarations | PMC10210318 | |||
Ethics approval and consent to participate | The study was conducted across multiple countries and institutions and was approved by all relevant ethics committees and national authorities. Belgium: Medical Ethics Committee UZ Brussel—Ref 2017/122, Denmark: Capital Region of Denmark—Centre for Health—Scientific ethics Committee—Ref: H-17009698, France: Comité de P... | PMC10210318 | ||
Consent for publication | Data of individual patients were de-identified and used for statistical analysis; no individual patient data are presented in the manuscript. | PMC10210318 | ||
Competing interests | LVE, Nordisk, NB, Diabetes | KIDNEY, APC, DIABETES | JVR, VC, RRA, EG, NB, LVE, MVM, and PV are employees or contractors of Imcyse S.A., Liège, Belgium, and may hold stock options. RDL’s institution received study funding and materials from Imcyse. RDL received an honorarium from DMRR and took part in advisory boards for Diamyd and Provention. MAA’s institution received ... | PMC10210318 |
References | PMC10210318 | |||
Background | candidiasis, RAU | CANDIDIASIS, RECURRENT APHTHOUS ULCER | Although topical steroids constitute the first-line therapy for recurrent aphthous ulcers (RAUs), their long-term use often leads to candidiasis. Although cannabidiol (CBD) can be an alternative for pharmacologically managing RAUs due to its analgesic and anti-inflammatory in vivo effects, there is a lack of clinical a... | PMC9940329 |
Methods | ulcer, Pain, RAU | ULCERS, ULCER | A CBD patch test was performed on 100 healthy subjects. CBD was applied on the normal oral mucosa of 50 healthy subjects 3 times/day for 7 days. Oral examination, vital signs, and blood tests were performed pre- and post-CBD use. Another 69 RAU subjects randomly received one of three topical interventions: 0.1% CBD, 0.... | PMC9940329 |
Results | TA reduced, ulcer, allergic reactions, pain | ULCER, ALLERGIC REACTION | None of the subjects exhibited allergic reactions or side effects. Their vital signs and blood parameters were stable before and after the 7-day CBD intervention. CBD and TA significantly reduced ulcer size more than placebo at all time points. The erythematous size reduction was higher in the CBD intervention than the... | PMC9940329 |
Conclusions | ulcer, RAU | ULCER | Topical 0.1% CBD reduced ulcer size and accelerated ulcer healing without side effects. CBD exerted anti-inflammatory effects in the early stage and an analgesic effect in the late RAU stage. Thus, topical 0.1% CBD might be more appropriate for RAU patients who decline to take topical steroids, except for cases where C... | PMC9940329 |
Trial registration | Thai Clinical Trials Registry (TCTR) Number TCTR20220802004. Retrospectively registered on 02/08/2022. | PMC9940329 | ||
Keywords | PMC9940329 | |||
Background | pseudomembranous, inflammation, pain, RAU, ulcer | INFLAMMATION, RECURRENT APHTHOUS ULCER, ULCER, ADVERSE EFFECT | Recurrent aphthous ulcer (RAU) is the most common painful oral lesion and affects patients’ quality of life (QoL) [RAU presents as an ovoid or round well-defined ulcer, with a pseudomembranous yellowish gray center, and an erythematous circumscribed border [Currently, there are no curative therapies for RAU. Thus, RAU ... | PMC9940329 |
Methods | PMC9940329 | |||
CBD preparation | A 5%w/w CBD (CBD-5CC) extract was obtained from | PMC9940329 | ||
Study design and sample | The clinical phases of this study were conducted at the Oral Medicine Clinic, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand and performed with informed consent following protocols approved by the Human Research Ethics Committee of the Faculty of Dentistry, Chulalongkorn University (certificate numbe... | PMC9940329 | ||
Phase 1: CBD patch test outcomes on human skin | allergic reaction, allergic reactions | CONTACT DERMATITIS, CONTACT DERMATITIS, ALLERGIC REACTION | To investigate the possible allergic reactions on the skin (e.g., contact dermatitis) while using CBD oral paste, 100 healthy subjects (50 males and 50 females, 18–65 years old) were recruited to participate in this study. 0.1% CBD was loaded in four Finn Chambers (Epitest, Tuusula, Finland) and placebo (pure oral past... | PMC9940329 |
Phase 2: CBD safety clinical outcomes after application on normal oral mucosa | To assess the local and systemic side effects of CBD oral paste after applying it on healthy oral mucosa, 50 healthy subjects (25 males and 25 females, 18–65 years old) were recruited to participate in this study. The subjects were instructed to apply CBD over their lower labial mucosa with a provided calibrated spoon ... | PMC9940329 | ||
Phase 3: CBD efficacy outcomes in subjects with RAU | PMC9940329 | |||
Study design | RAU | A randomized parallel double-blind controlled trial design was performed in phase 3. To measure the efficacy of CBD for treating RAU, 72 subjects with RAU randomly received one of three topical interventions: 0.1% CBD, 0.1% triamcinolone acetonide (TA), or placebo using simple randomization according to a manually gene... | PMC9940329 | |
Sample size | ulcer | ULCER | The sample size was calculated using the G*Power program version 3.1.9.7 for 80% power, 95% confidence level, and 0.4 effect size according to the range of ulcer sizes reported in a previous study [ | PMC9940329 |
Subjects | allergy, ulcers, Crohn’s disease, Behcet’s disease, RAU, anemia, diabetes mellitus, ulcer, trauma | SYSTEMIC DISEASE, MINOR, ALLERGY, INFECTIONS, ULCERS, ANEMIA, DIABETES MELLITUS, APHTHOUS ULCERS, ULCER | The subjects fulfilled the following inclusion criteria: age between 18–65 years old, willing to participate and provide informed consent, and had a history of RAU (at least 2 times/year) on nonkeratinized oral mucosa, presenting with 1–3 minor aphthous ulcers (of ≤ 48 h duration) that were 2–10 mm in diameter and easi... | PMC9940329 |
Allocation concealment and blinding | The pharmacological compounds were sealed in sequentially numbered identical containers. The placebo was matched to the CBD oral paste for taste, color, appearance, and smell. A research assistant (WK) generated the random allocation sequence, enrolled the subjects, and assigned the subjects to the interventions. The s... | PMC9940329 | ||
Interventions | ulcer, ulcers, RAU | ADVERSE REACTIONS, ULCERS, ULCER | The subjects were randomly placed into one of the three interventions: 0.1% CBD, 0.1% TA, or placebo. Seventy-two subjects (24 subjects for each intervention) were enrolled in this study. The interventions were applied with a provided calibrated spoon to the ulcers 3 times/day after meals for 7 days. When the subjects ... | PMC9940329 |
Outcomes | PMC9940329 | |||
Ulcer severity score (USS) | ulcer, pain | DISEASE, ULCER | The USS is indicative of the disease severity. This score incorporated six ulcer characteristics: number, size, duration, ulcer-free period, site, and pain [ | PMC9940329 |
Ulcer size | pseudomembranous ulcer, ulcer, ulcers | ULCER, ULCERS | The ulcer size was measured on day 0, 2, 5, and 7. Two ulcer size parameters consisting of the pseudomembranous ulcer size and erythematous border size were measured. The ulcer diameters were measured using a calibrated dental probe with millimeter markings, and the ulcer sizes were calculated using formulas for the su... | PMC9940329 |
Daily pain ratings | Pain, pain | Pain ratings using a visual analog scale (VAS) consisting of a 100-mm horizontal line between the endings marked “no pain” and “unbearable pain” were recorded daily by the subjects. | PMC9940329 | |
Subject satisfaction | On the last day, the subjects rated their satisfaction with the intervention used on a scale of 0 (not satisfactory) to 10 (the most satisfactory). The subjects who used all three topical interventions were asked to rank the interventions according to their preference (from most to least preferred). | PMC9940329 | ||
QoL improvement | The subjects completed a QoL questionnaire using the Thai Oral Health Impact Profile-14 (OHIP-14) at the first and last visit. | PMC9940329 | ||
Statistical analysis | pseudomembranous ulcer, pain | The background and demographic data were summarized using descriptive statistics. In phase 2, the normal distribution for each variable was determined using the Shapiro–Wilk test. Matched paired differences of vital signs and blood tests before and after CBD use were analyzed using the paired t-test (normally distribut... | PMC9940329 | |
Results | PMC9940329 | |||
Phase 1: CBD patch test outcomes on human skin | erythema, allergic reactions | ERYTHEMA, CONTACT DERMATITIS, ALLERGIC REACTION, ULCERATION | None of the subjects exhibited allergic reactions (signs of erythema, vesicles, or ulceration) or contact dermatitis on any CBD-treated area. | PMC9940329 |
Phase 2: CBD safety clinical outcomes after application on normal oral mucosa | jaundice, liver dysfunction, nausea,, pain | ADVERSE REACTION, ANAPHYLACTIC REACTION, ALLERGIC REACTION | None of the subjects experienced or reported an obvious adverse reaction (irritant response or allergic reaction) on their oral mucosa. Furthermore, no anaphylactic reactions were observed in the respiratory or circulatory system and no signs of liver dysfunction were reported (e.g., nausea, vomiting, jaundice, right u... | PMC9940329 |
Ulcer size reduction | pseudomembranous ulcer, Pseudomembranous ulcer, ulcer | REMISSION, ULCER | The ulcer size was adjusted to a percentage compared with baseline (100%). The ulcer size reduction analysis among the three interventions indicated that the pseudomembranous ulcer size was almost 100% smaller in the CBD group on day 5 (Fig. Pseudomembranous ulcer size reduction. The Y-axis values represent percentages... | PMC9940329 |
Daily pain ratings | ulcer pain, pain | The ulcer pain scores (VAS) were adjusted to a percentage compared with baseline (100%). Comparing the daily pain ratings between the three interventions, topical CBD and TA decreased the pain levels from day 1 onwards, while the placebo markedly increased the pain levels on day 1–2 and then gradually decreased the pai... | PMC9940329 | |
Subject satisfaction with topical interventions | The subjects who received the TA and CBD topical interventions were more satisfied with the intervention (average satisfaction score of 8.32 vs. 7.48, respectively,At the end of the study, four subjects had been treated with all three interventions. When these subjects ranked the interventions in order of preference, t... | PMC9940329 | ||
QoL improvement | The statistical analysis of the OHIP-14 score reduction in each group revealed that the three interventions significantly reduced the OHIP-14 scores between first and last visit ( | PMC9940329 | ||
Discussion | allergic reaction, ulcer size reduction, pain, RAU, pseudomembranous ulcer, ulcer | ULCER, ALLERGIC REACTION, HEALING ULCERS | In recent years, complementary and alternative medicine (CAM) has been increasingly used worldwide. CAM is defined as a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine [The present study evaluated the use of 0.1% CBD as a to... | PMC9940329 |
Conclusions | allergic, alcohol addiction, mood disorders, RAU, pain, ulcer | ULCER | This clinical study demonstrated that topical 0.1% CBD reduced ulcer size and accelerated ulcer healing without any reported local (signs of allergic and anaphylactic reactions) or systemic (vital sign and blood test alteration) side effects. Furthermore, in the RCT, topical CBD exerted an anti-inflammatory effect by r... | PMC9940329 |
Acknowledgements | We thank Dr. Joao Ferreira for his assistance in reviewing this manuscript, Dr. Kevin Tompkins for his assistance in revising the English language, Dr. Witchapat Kengtong for his kind assistance as a research assistant, and Dr. Nawaporn Pengpis for all support. | PMC9940329 | ||
Authors’ contributions | KB contributed to the study conception and design, funding acquisition, methodology, project administration, supervision, and writing-review & editing. CU contributed to data collection, formal analysis and interpretation of the data, investigation, validation, visualization, and writing-original draft. DC and JL prepa... | PMC9940329 | ||
Funding | This study was funded by Thailand Science Research and Innovation Fund Chulalongkorn University (CU_FRB65_hea (1)_007_32_02). | PMC9940329 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC9940329 | ||
Declarations | PMC9940329 | |||
Ethics approval and consent to participate | The present study was performed with informed consent following protocols approved by the Human Research Ethics Committee of the Faculty of Dentistry, Chulalongkorn University (certificate number HREC-DCU 2021–048 approved on 9 July 2021). Informed consent was obtained from all subjects. All methods were performed in a... | PMC9940329 | ||
Consent for publication | Not applicable. | PMC9940329 | ||
Competing interests | The authors declare no competing interests. | PMC9940329 | ||
References | PMC9940329 | |||
Introduction | low anterior resection syndrome | LOW ANTERIOR RESECTION SYNDROME | The incidence of low anterior resection syndrome (LARS) has increased over time owing to an increasing rate of sphincter-sparing surgery | PMC10416684 |
Methods | enema, colorectal or coloanal anastomosis | This multicentre (7 centres) open-label RCT included patients with a low colorectal or coloanal anastomosis who had major LARS (LARS score at least 30)SOC was delivered by the treating physician to every patient based on a pathway of bowel management, including a low-fibre diet, laxatives and/or loperamide, physiothera... | PMC10416684 | |
Results | abdominal spasms, lower anterior resection syndrome, pain | INCONTINENCE, ADVERSE EVENTS, SECONDARY, SYNDROME, EVENTS | Some 64 patients with severe LARS were considered eligible. Of these, 32 (22 men) met the inclusion criteria and were randomized. One patient in each group was excluded (1 performed TAI in SOC group and was excluded; 1 deferred performing the enemas in TAI group and was no longer eligible) (Study flow chart and changes... | PMC10416684 |
Discussion | RECTAL PERFORATION | In this study, there was a marked improvement in LARS score in patients using TAI compared with the SOC group at study termination after 3 months. These positive results of TAI with a cone mirror outcomes reported in other preliminary studies with a balloon catheterSelection of the best candidates for colonic irrigatio... | PMC10416684 | |
Supplementary Material | Click here for additional data file. | PMC10416684 | ||
Funding | This study was promoted and funded by Coloplast. Coloplast provided the medical device and support for study design, data collection, and statistical analysis. | PMC10416684 | ||
Author contributions | HANSEN | Guillaume Meurette (Conceptualization, Formal analysis, Investigation, Project administration, Supervision, Writing—original draft, Writing—review & editing), Jean Luc Faucheron (CRediT contribution not specified), Eddy Cotte (Investigation, Writing—review & editing), Quentin Denost (Investigation, Writing—review & edi... | PMC10416684 | |
Disclosure | A.W. H., who is currently an employee of Coloplast, participated in the study design and management, but without commercial involvement in the device itself. The authors declare no other conflict of interest. G.M is member of Coloplast Medical Advisory Board. | PMC10416684 | ||
Supplementary material | PMC10416684 | |||
Data availability | All the data reported in this study are available for further information (clinical trial identifier NCT04586634). | PMC10416684 | ||
References | PMC10416684 | |||
Subject terms | SECONDARY, RECURRENCE, RECTAL CANCER | Traditional total mesorectal excision (TME) for rectal cancer requires partial resection of Denonvilliers’ fascia (DVF), which leads to injury of pelvic autonomic nerve and postoperative urogenital dysfunction. It is still unclear whether entire preservation of DVF has better urogenital function and comparable oncologi... | PMC10589235 | |
Introduction | Rectal cancer | MALIGNANT TUMORS, RECURRENCE, RECTAL CANCER, RECTAL CANCER | Rectal cancer (RC) is one of the most common malignant tumors in the worldTraditional TME surgery required dissection anterior to Denonvilliers’ fascia (DVF) and thus DVF should be partly resectedWith studies on both cadavers and surgical videos, we demonstrated a surgical landmark line for intraoperative identificatio... | PMC10589235 |
Results | PMC10589235 | |||
Study population | MAY | From August 26, 2015, through May 6, 2020, a total of 262 patients were enrolled and randomly assigned to the Exp-group or Con-group ( | PMC10589235 | |
Urogenital functions | According to protocol, patients undergoing Non-R | PMC10589235 | ||
Postoperative recovery and surgical outcomes | As shown in Supplementary Table | PMC10589235 | ||
Overall survival and disease-free survival | cardiovascular deaths, stroke, tumor-related deaths, non-tumor-related diseases | STROKE | At the last follow-up, 40 patients (16.5%) had died, the median follow-up time was 51.9 months. Among them, 4 cases died from non-tumor-related diseases, containing 2 cases of cardiovascular deaths, 1 case of stroke, and 1 case of traffic accident. Taking together, there were 36 cases (14.9%) of tumor-related deaths in... | PMC10589235 |
Overall Survival (OS) for laparoscopic total mesorectal excision (TME) with Denonvilliers’ fascia preservation (Exp-group) vs laparoscopic TME with Denonvilliers’ fascia resection (Con-group) at 3 years after surgery. | Kaplan–Meier method was used to estimate survival probabilities over time and the log-rank test was applied to compare survival curves between two groups. We set truncation at 36 months for restricted mean survival time (RMST). The RMST in the Exp-group was 35.50 months (95% CI, 35.05–35.94 months). Correspondingly, th... | PMC10589235 | ||
Recurrence rate and pattern | RECURRENCE, RECURRENCE, METASTASIS, LUNG METASTASIS, LIVER METASTASIS | At the last follow-up, 37 patients (15.3%) were diagnosed with recurrence, containing 9 cases of local recurrence (24.3%), 12 cases of liver metastasis (32.4%), 13 cases of lung metastasis (35.1%) and 3 cases of peritoneal metastasis (8.1%). As shown in Table Recurrence rate and pattern of patients in the modified inte... | PMC10589235 | |
Discussion | obesity, tumor, urinary dysfunction | OBESITY, TUMOR, TUMOR RECURRENCE, RECURRENCE, COMPLICATION, DYSFUNCTION, CAVITY, RECTAL CANCER | Urogenital dysfunction has become the major complication of total mesorectum excision (TME) for low-mid rectal cancer. In this study, we revealed that compared with traditional TME surgery, TME surgery with Denonvilliers’ fascia (DVF) preservation had better postoperative urogenital function, with a comparable oncologi... | PMC10589235 |
Methods | PMC10589235 | |||
Study design | The PUF-01 trial is an open-label, multicenter, randomized clinical trial conducted at 11 centers in China. The trial was registered on ClinicalTrials.gov on April 26, 2015 ( | PMC10589235 | ||
Participants | MAY | Patients were enrolled from August 26, 2015, through May 6, 2020. Eligibility criteria were listed in (Supplementary Table There were two reasons why only male patients were enrolled in this study. First, the structure of DVF was more complicated and multiple-morphologic for females, thus the feasibility of DVF preserv... | PMC10589235 | |
Randomization and blinding | This study is an open-label and a single-blind design is adopted in this study. Stratified blocked randomization was used, the stratification factor was center, and the block size was 4. The random allocation sequence was generated by a statistician who was independent of the research, using the SAS 9.3 software (SAS I... | PMC10589235 | ||
Interventions | tumor, pain | TUMOR | Following randomization, laparoscopic TME surgery was performed. In the Con-group, dissection of the anterior rectum was performed anterior to DVF, and the fascia was resected by an “inverted U-shaped” incision ≥2 cm beneath the tumor. In contrast, for the Exp-group, dissection was performed posterior to DVF and thus D... | PMC10589235 |
Outcome measures | death, Prostate | RETROGRADE EJACULATION, RECURRENCE, ANEJACULATION, EVENT, PROSTATE, DISEASES | The patients’ urinary function was evaluated by RUV (mL, by ultrasonography), maximum flow rate (MFR, mL/s, by urodynamics), and International Prostate Symptom Score (IPSS). Erectile function and ejaculation function were evaluated by IIEF-5 and ejaculation function grading (Grade I: normal ejaculation; Grade II: retro... | PMC10589235 |
Sample size calculation | sexual dysfunction, urinary dysfunction | DYSFUNCTION | In this study, the incidences of urinary dysfunction 2 weeks postoperatively and sexual dysfunction 12 months postoperatively were the primary endpoints and dominant evaluation indicators. In our previous study, the incidence of urinary dysfunction and sexual dysfunction were 24.39% and 9.76%, respectively, for DVF-pre... | PMC10589235 |
Statistical analysis | REGRESSION | DFS and OS were evaluated by the Kaplan–Meier method and compared by the log-rank test. The Cox proportional hazards regression model was used to estimate the adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for the effect of surgical approach on DFS and OS. The “survminer” package in R was used to provi... | PMC10589235 | |
Reporting summary | Further information on research design is available in the | PMC10589235 | ||
Supplementary information |
Supplementary InformationReporting SummaryPeer Review File | PMC10589235 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-42367-3. | PMC10589235 | ||
Acknowledgements | We thank Professor R.J. Heald for his guidance and generous help during the study. We thank Hao Chen (Nanfang Hospital of Southern Medical University, China) for the consultation. We thank Dr. Yang Shuo and Dr. Luo Hao (Department of Epidemiology and Biostatistics, School of Public Health; Sun Yat-Sen University), Xiao... | PMC10589235 | ||
Author contributions | C.H., G.W. | J.F. and H.W. contributed to design and writing. B.W., Z.Z., J.Z., J.L. X.Y., T.C., Y.H., J.H., and J.L. contributed acquisition, analysis, and interpretation of data. J.X., F.H., M.H., Q.X., X.W., C.H., G.W., Y.J., G.S., and H.D. contributed surgical support. | PMC10589235 |
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