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Conclusion
This study suggests that video-based SA training for laparoscopic novices has a positive impact on performance and error rate. SA training should thus be included as one aspect besides simulation and real cases in a multimodal curriculum to improve the efficiency of laparoscopic surgical skills training.
PMC10234874
Supplementary Information
The online version contains supplementary material available at 10.1007/s00464-023-10006-z.
PMC10234874
Keywords
cognitive skills
Open Access funding enabled and organized by Projekt DEAL.Minimally invasive surgery (MIS) has replaced open procedures as the gold standard in many areas of surgery. This includes simple procedures, such as laparoscopic appendectomy or cholecystectomy [The paradigm shift in training methodology toward a competency-bas...
PMC10234874
Materials and methods
PMC10234874
Setting and participants
This study was conducted as a voluntary elective course for medical students in their clinical (3rd to 6th) years at the Medical Faculty of the University of Heidelberg, Germany. The course took place at the MIS Training Center of the Department of General, Visceral and Transplant Surgery. Only laparoscopy-naïve studen...
PMC10234874
Study design
This was a prospective, single-center, two-arm, blinded, parallel-group randomized trial. Randomization was performed by a computer-based program and kept safe in sealed opaque and numbered envelopes. There was structured training for the tutors rating the same video clips to ensure inter-rater quality. In order to avo...
PMC10234874
SA training
The intention of the intervention was to train SA. According to Endsley [Extract of the intervention training for situational awareness during LCThe SA training within the curriculum comprised three parts of video sessions. Each video session consisted of two parts:Distinction between the cystic artery, bile duct, and ...
PMC10234874
Baseline
Prior to training, all participants completed a questionnaire about relevant previous experiences. Questions involved prior experience in the OR, especially in general laparoscopic procedures and open cholecystectomy along with personal characteristics that may be associated with higher performance in (laparoscopic) su...
PMC10234874
Pre-test
After an introduction to LC via touch surgery, a validated serious game [CONSORT Flow diagram of the study design
PMC10234874
Post-test
The post-test was performed under the same conditions as the pre-test. At the end of the training, all participants completed another questionnaire evaluating the training, focusing on cognitive training.
PMC10234874
Study hypothesis
The difference in the OSATS score was defined as the primary outcome.HH
PMC10234874
Sample size calculation
The sample size determination was calculated with a t test, assumptions from experiences of previous studies and the results of the pilot study. The assumptions made were a significance level of 5%, a standard deviation of 13 and a group difference of 10 points on the OSATS score. Accounting for a drop-out rate of 25%,...
PMC10234874
Statistical analysis
Statistical analysis was performed using R [
PMC10234874
Primary outcome
REGRESSION
Confirmative testing was performed looking for superiority in the OSATS score at the post-test.As predefined in the protocol, a stepwise linear regression was used to test the hypothesis. Possible influencing variables were selected beforehand. These were ranked by relevance and significance and gradually removed durin...
PMC10234874
Secondary outcomes
Exploratory analysis was performed by looking for group differences in the post-test of the GOALS Score, the error score, and the total procedure time in minutes. These analyses were performed using the unpaired t tests with equal variances. The individual sub-items of the error score were analyzed with Chi-Square test...
PMC10234874
Results
Data from 61 students were available for analysis. A detailed overview of baseline characteristics is provided in Table Demographic data*Absolute (in percent)
PMC10234874
Primary outcome
REGRESSION
The SA intervention resulted in a significant improvement in performance measured with the OSATS score (SA: 67.0 ± 11.5 versus control: 59.1 ± 14.0, Linear regression model with post-test OSATS score as the dependent variableBold values indicate group significantly impacts performance
PMC10234874
Subgroup analysis
ADVERSE EFFECTS
Subgroup analysis did not reveal any unexpected adverse effects attributed to the intervention. Furthermore, no interaction between intervention and subgroup was detected (see supplementary file, Fig. Rainforest plot illustrating subgroup analysis
PMC10234874
Discussion
mistakes
The present randomized study shows that SA training as part of a multimodal training concept can lead to a significant improvement in laparoscopic performance during the early learning curve. The results were consistent in exploratory analyses for additional performance metrics and error rates. Significant group differ...
PMC10234874
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (MP4 11248 KB)Supplementary file2 (MP4 5251 KB)
PMC10234874
Acknowledgements
The present study is part of Ms. Laura Seifert’s doctoral thesis at Heidelberg University.
PMC10234874
Author contributions
Study conception and design: NF, KKF, and SMW. Acquisition of data: SL, KKF, AS, and FC. Statistical analysis: SL, BL, and KKF. Analysis and interpretation of data: SL, KKF, and NF. Drafting of manuscript: SL and KKF. Critical revision: MSBP and NF.
PMC10234874
Funding
Open Access funding enabled and organized by Projekt DEAL.
PMC10234874
Declarations
PMC10234874
Disclosures
SCHMIDT
Karl-Friedrich Kowalewski, Laura Seifert, Laura Kohlhas, Mona Wanda Schmidt, Seher Ali, Carolyn Fan, Karl Felix Köppinger, Beat Müller-Stich, and Felix Nickel have no conflicts of interest or financial ties to disclose.
PMC10234874
References
PMC10234874
1. Introduction
cancer, tumor
CANCER, TUMOR
Curcumin is a natural ingredient with antioxidant effects, widely studied as a treatment for various types of cancer. However, its effects on ultraviolet radiation have not been fully explored. The effects of single or daily application of 0.1–100 μM curcumin on cell apoptosis in ultraviolet B (UVB)-induced mice were t...
PMC9824043
3. Discussion
inflammation, death, tumor necrosis, ultraviolet exposure-induced apoptosis
TUMOR NECROSIS, INFLAMMATION, AUTOIMMUNE DISEASES, MALIGNANCIES, OXIDATIVE STRESS, DISEASES
Cell apoptosis or programmed cell death serves as an integral part of cellular homeostasis. An increase in the abnormal viability of cells influenced by endogenous or exogenous factors can lead to the development of various diseases, most prominently malignancies and autoimmune diseases. The protein family BCL-2 is res...
PMC9824043
4. Methods
PMC9824043
4.1. Study Design and Subject
ALBINO
The study was a double-blind experimental posttest design with a control group, conducted at the Hasanuddin University Animal Laboratory, Makassar, Indonesia. Healthy male Swiss albino mice aged 6–9 weeks and weighing 20–30 g were maintained under a temperature of 28 °C ± 2 °C and humidity of 50% ± 10% for a minimum of...
PMC9824043
4.2. Study Protocol
Two experimental models were used: a single application of various curcumin concentrations before a single UVB exposure and daily application of various curcumin doses for 7 days before a single UVB exposure on the seventh day. The mice were randomly allocated to 11 groups, each containing five mice. Group 1 received n...
PMC9824043
4.3. Cell Apoptosis Activity Examination
The apoptotic cells among the squamous epithelial cells in all epidermis layers were counted histopathologically using the Apo-BrdU-IHC Kit TUNEL System (Biovision
PMC9824043
4.4. Data Analysis
Data analysis was conducted using SPSS 18.0 for Windows (SPSS Inc. Chicago, IL, USA). The statistical tests used were one-way ANOVA for comparison between groups in each experimental design and the
PMC9824043
5. Conclusions
Topical curcumin can act as a photoprotective agent by preventing cell apoptosis in UVB-induced mice. In terms of daily application and increasing concentration, 100 μM curcumin treatment was associated with the smallest number of histopathologically observed apoptotic cells after a single UVB exposure. However, at low...
PMC9824043
Author Contributions
Conceptualization, K.D., M.N.M. and I.Y.; methodology, U.A.M., I.J.P. and M.F.; software, I.J.P. and M.F.; validation, K.D., M.N.M. and U.A.M.; formal analysis, I.J.P. and M.F.; investigation, K.D.; resources, K.D.; data curation, I.J.P. and M.F.; writing—original draft preparation, K.D.; writing—review and editing, K....
PMC9824043
Institutional Review Board Statement
This study obtained ethics approval from the local ethics committee board (UH07100058).
PMC9824043
Informed Consent Statement
Not applicable.
PMC9824043
Data Availability Statement
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC9824043
Conflicts of Interest
The authors declare no conflict of interest.
PMC9824043
Sample Availability
Samples of the compounds are available from the authors.
PMC9824043
References
Induction of apoptosis in UVB-irradiated mice. Pretreatment with topical curcumin before UVB irradiation prevented apoptosis in both experimental models.Apoptotic cells, indicated by brown staining in the nuclei (arrow), at 400× magnification under an Olympus Type CX-31 microscope, in the UVB-only group with majority a...
PMC9824043
Background
impairment of primary Osteoarthritis
OSTEOARTHRITIS OF THE KNEE
This primary analysis evaluated the “PREVenting the impairment of primary Osteoarthritis by high-impact long-term Physical exercise regimen—Psychological Adherence Program” (PrevOP-PAP), designed to support patients with osteoarthritis of the knee (OAK) to engage in regular moderate-to-vigorous physical activity (MVPA)...
PMC10318642
Methods
Participants with radiographically verified moderate OAK (
PMC10318642
Results
MVPA (12 months) did not mediate effects of the PrevOP-PAP on WOMAC scores (24 months). Compared to the active control condition, WOMAC scores (24 months) were lower in the intervention condition, but this effect did not remain stable in sensitivity analyses (
PMC10318642
Conclusions
Compared to an active control condition, the PrevOP-PAP did not produce reliable effects on WOMAC scores and none on preceding MVPA. Of the HAPA-proposed volitional precursors, only action planning was sustainably increased. Future interventions should use m-health applications to digitally support long-term changes in...
PMC10318642
Trial registration
German Clinical Trials Register;
PMC10318642
Supplementary Information
The online version contains supplementary material available at 10.1186/s12891-023-06661-x.
PMC10318642
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10318642
Background
age-related disease, pain
OSTEOARTHRITIS OF THE KNEE
Osteoarthritis of the knee (OAK) is a highly prevalent, progressive, age-related disease that causes pain and stiffness of the affected joint, causing reductions in individuals’ quality of life [Although patients with OAK report strong intentions to adapt their lifestyles to relieve severity or slow progression of OAK ...
PMC10318642
Research question and hypotheses
In a population of individuals with moderate OAK, the present study addresses the following primary research question: Is there an indirect effect of a HAPA-based psychological intervention (PrevOP-PAP intervention), consisting of a motivational intervention and a volitional intervention including network formation, on...
PMC10318642
Method
PMC10318642
Procedure, randomization, and design
TIDieR
The PrevOP-PAP was an unblinded randomized controlled trial embedded in a parallel group design with the PrevOP-PAP crossed within the same sample of the PrevOP-Main Medical Trial (PrevOP-MMT; preregistered at [Consolidated Standards of Reporting Trials (CONSORT) diagram depicting participant flow through the studyThe ...
PMC10318642
Power, recruitment, and inclusion
For the PrevOP-PAP, with an alpha level of 0.05 and a stability factor of 0.68 of the measure to assess the primary outcome (OAK symptoms as measured by the WOMAC [With an expected drop-out rate of 20%, the required sample size increased to Inclusion and exclusion criteria were mostly relevant for the medical PrevOP-MM...
PMC10318642
Masking
PrevOP-PAP intervention content could not be masked for study staff or participants. Study staff were aware of participants’ study group allocation at the beginning of the first intervention session of the PrevOP-PAP. Moreover, data analyses were conducted by N.L., N.K., and R.S. and were also unmasked.
PMC10318642
Intervention content
All intervention contents were delivered in German, derived from theory-based established intervention programs in primary and tertiary prevention settings [
PMC10318642
Brief motivational intervention
Before randomization, all participants received a brief motivational intervention delivered by trained study staff that consisted of a brochure that participants were asked to read, followed by a brief quiz in form of a cross-word puzzle to test knowledge transfer. The brochure introduced participants to different inte...
PMC10318642
PrevOP-PAP intervention: computer-assisted face-to-face intervention
pain
The computer-assisted face-to-face intervention, again delivered by trained study staff, consisted of an introductory section that reminded participants of the program’s goals, four ensuing sections focussing on outcome expectancies, self-efficacy, goal setting, planning, and a feedback section [Outcome expectancies we...
PMC10318642
PrevOP-PAP intervention: computer-assisted phone-based intervention and activity calendars
outcome(s
Trained staff (i.e., trained Bachelor’s and Master’s students of psychology employed as students research assistants in the trial) followed a computer-based structured intervention [To increase maintenance self-efficacy and recovery self-efficacy, participants were first asked to review their PA-plan pursuit and indica...
PMC10318642
Measures
The present article used data relevant for the analysis of the pre-registered primary research question under study [
PMC10318642
OAK symptoms
The primary endpoint was self-reported OAK symptoms at M24 assessed with the WOMAC in its version for OAK administered in German [
PMC10318642
Moderate-to-vigorous physical activity (MVPA)
Daily MVPA (in minutes) averaged over one week as assessed with tri-axial accelerometer devices (ActiGraph GT3X, Pensacola, Fl) at M0 and M12 were used in the present analyses. Participants were instructed to wear the devices at their right hip during waking hours for one week at each assessment period. Using an algori...
PMC10318642
HAPA-proposed volitional precursors of MVPA change
All HAPA-defined volitional precursors of MVPA change addressed in the PrevOP-PAP intervention were included in the manipulation checks, including assessments at M0 and M24. They were adapted from prior research [
PMC10318642
Behavioral intentions and covariates
Behavioral intentions as assessed at M0 and one week after the motivational treatment received by all participants were measured with 4 items (M0 α = 0.81; one week after M0 α = 0.76; [
PMC10318642
Statistical analyses
SENSITIVITY
Analyses were conducted using R Statistical Software (v4.2.2 [To benefit from full-information maximum likelihood procedures to retain all available data in models and perform analyses with an intent-to-treat approach [Sensitivity analyses for the primary hypothesis test included several groups of covariates: BMI (rang...
PMC10318642
Results
PMC10318642
Attrition analyses and randomization check
Participants dropping out before M24 (
PMC10318642
Discussion
This primary analysis report evaluated outcomes of the psychological adherence program PrevOP-PAP that was designed to enhance PA and reduce OAK symptoms (WOMAC) among patients with moderate OAK. The intervention program PrevOP-PAP adopted motivational, volitional, and networking intervention strategies based on the HA...
PMC10318642
Indirect effects of the PrevOP-PAP intervention on OAK symptoms via MVPA
osteoarthritis, pain
OSTEOARTHRITIS, STILL
Compared to the control group, intervention effects on overall OAK symptoms (WOMAC) trended towards a decrease at the end of the study period. Contrary to our hypothesis, this effect did no longer reach statistical significance in sensitivity analyses. Still, exploratory follow-up analyses with different domains of OAK...
PMC10318642
Effects of the PrevOP-PAP intervention on MVPA and its HAPA-proposed volitional precursors
pain
DISEASE
Importantly, the question arises why participants did not increase their MVPA during the intervention period. On the one hand, increases in intentions to engage in regular MVPA one week after the motivational intervention indicated a successful motivational manipulation for all participants. However, manipulation check...
PMC10318642
Strengths and limitations
This study has several strengths. First, this RCT included a long follow-up period up to 24 months post study entry (i.e., 12 months following the intervention period) to elucidate causal mechanisms of the PrevOP-PAP intervention in the long term. The intervention program PrevOP-PAP was based on theoretically-derived h...
PMC10318642
Conclusions
pain
DISEASE
This psychological adherence program was based on HAPA-derived behavior change techniques and specifically designed for patients with moderate OAK to facilitate the uptake and maintenance of physical activity. Whereas levels of action planning significantly increased following the intervention, primary analyses did not...
PMC10318642
Acknowledgements
FRANK
In grateful memory of Dieter Felsenberg.Authors also wish to thank the teams of PrevOP-PAP and PrevOP-MMT for their dedicated work and contributions to the projects: Daniela Lange, Diana Hilda Hohl, Susannah Motter, Luisa Wirth, Lisa Bosch, Theresa Reschke, Annekathrin Teichmann, Eva Marie Keinert, Patrick Klaiber, Ulr...
PMC10318642
Protocol version and trial status
This is the primary analyses report as registered with the German Clinical Trials Register on 26 January 2016. No trial registry modifications were undertaken. With regard to the study protocol [
PMC10318642
Authors’ contributions
RECRUITMENT
N.K. and R.S. (principal investigators of PrevOP-PAP) and N.L. (PrevOP-PAP study researcher): statistical analyses and first draft of the manuscript. J.K., A.D., and S.D.M.: (PrevOP-PAP study researchers): coordination of PrevOP-PAP. G.A. and H.B. (PrevOP-MMT study researchers): coordination of PrevOP-MMT. P.M. (princi...
PMC10318642
Funding
Open Access funding enabled and organized by Projekt DEAL. This work is part of the overarching OVERLOAD-PrevOP consortium (
PMC10318642
Availability of data and materials
The datasets generated and analyzed during the current study are available from the corresponding author upon request.
PMC10318642
Declarations
PMC10318642
Ethics approval and consent to participate
The ethics committee of the Charité – Universitätsmedizin Berlin approved this study (EA4/027/15). All procedures were carried out in compliance with the Helsinki Declaration. Before inclusion into the study by PrevOP-MMT medical personnel, written informed consent was obtained from each participant for participation i...
PMC10318642
Consent for publication
Not applicable.
PMC10318642
Competing interests
The authors declare no competing interests.
PMC10318642
References
PMC10318642
BACKGROUND
Weight-loss diets often target dietary fat or carbohydrates, macronutrients that are sensed via distinct gut-brain pathways and differentially affect peripheral hormones and metabolism. However, the effects of such diet changes on the human brain are unclear.
PMC10371234
METHODS
obesity
OBESITY
We investigated whether selective isocaloric reductions in dietary fat or carbohydrates altered dopamine D2/3 receptor binding potential (D2BP) and neural activity in brain-reward regions in response to visual food cues in 17 inpatient adults with obesity as compared with a eucaloric baseline diet using a randomized cr...
PMC10371234
RESULTS
On the fifth day of dietary fat restriction, but not carbohydrate restriction, both D2BP and neural activity to food cues were decreased in brain-reward regions. After the reduced-fat diet, ad libitum intake shifted toward foods high in both fat and carbohydrates.
PMC10371234
CONCLUSION
These results suggest that dietary fat restriction increases tonic dopamine in brain-reward regions and affects food choice in ways that may hamper diet adherence.
PMC10371234
TRIAL REGISTRATION
ClinicalTrials.gov NCT00846040 FUNDING. NIDDK 1ZIADK013037.
PMC10371234
Introduction
obesity
OBESITY
Among dietary approaches to treat obesity (People with obesity may have reduced dopamine synthetic capacity (
PMC10371234
Results
A subset of individuals for whom metabolic results were previously reported (
PMC10371234
Only the RF diet decreased activity in brain-reward regions in response to food cues.
CORTEX
Participants rated the pleasantness of a variety of food images during fMRI sessions 4.5 hours after lunch on the fifth day (third inpatient day) of the first eucaloric baseline diet period and on the fifth day of the RC and RF diets. Voxel-wise blood-oxygen-level-dependent (BOLD) responses to food images were compared...
PMC10371234
Only the RF diet led to decreased D2BP.
Participants completed PET imaging with the radiolabeled D2-like receptor subtype antagonist [Compared with baseline, the RF diet significantly decreased D2BP in bilateral striatal clusters spanning the left putamen and right caudate/putamen (The cluster where D2BP was decreased during the RF versus the baseline diet w...
PMC10371234
The RF diet resulted in greater ad libitum intake of foods high in both carbohydrate and fat.
We explored ad libitum food intake for 3 days after the RF and RC diets. Participants selected foods from computerized vending machines stocked with calories in excess of maintenance energy requirements. Average energy intake was (mean ± SEM) 25.9% ± 9.5% greater than the eucaloric baseline diet and was not significant...
PMC10371234
Discussion
weight gain, eating behavior
CAVITY
We previously showed that the RC diet led to widespread metabolic and endocrine changes compared with the eucaloric baseline diet, including increased fat oxidation as well as decreased energy expenditure and decreased daily insulin secretion, whereas the RF diet did not lead to substantial peripheral metabolic or endo...
PMC10371234
Limitations.
obesity, weight loss
OBESITY
While our interpretation of increased tonic dopamine is supported by relative pharmacokinetic properties of D1/5 and D2-like receptors, and literature on D2-like receptor PET occupancy and fMRI activity, we did not directly measure brain dopamine. Consumption of dietary fat elicits rapid dopaminergic response in reward...
PMC10371234
Methods
PMC10371234
Experimental model and subject detail
Twenty-one adults provided informed consent to participate in a randomized crossover trial investigating the effects of selective isocaloric reduction of dietary fat versus carbohydrates on macronutrient metabolism, striatal D2BP, and neural activity in response to food stimuli in brain-reward regions (ClinicalTrials.g...
PMC10371234
Study details
This study was conducted between February 13, 2009, and October 20, 2014. Volunteers were admitted to the NIH Clinical Center for a 14-day period to receive the eucaloric baseline diet for 5 days. After that, volunteers received either the RC or the RF diet for the next 6 days, followed by 3 days of ad libitum feeding ...
PMC10371234
Anthropometrics
Height was measured in centimeters using a wall stadiometer (Seca 242), and weight was measured in kilograms using a digital scale (Scale-Tronix 5702). All measurements were obtained after an overnight fast, while participants were wearing only hospital scrubs.
PMC10371234
Diets
ADVERSE EVENTS
All subjects were confined to the metabolic ward throughout the study without access to outside food. Meals were consumed under observation, and any uneaten food was returned to the kitchen and reweighed. Subsequent meals were adjusted to account for uneaten food as needed. Diets were designed using ProNutra software (...
PMC10371234
Baseline eucaloric diet.
The daily caloric content during the initial out-patient segment and the weight-maintenance phase was based on the resting energy expenditure measured at screening with an activity factor of 1.5. Beginning 2 days before each admission, participants were provided with a weight-maintenance diet using a standard diet comp...
PMC10371234
Reduced energy diets.
During the restricted diet phase (inpatient days 6–11), 30% of baseline calories were removed by selective reduction of either carbohydrate (RC diet) or fat (RF diet) while keeping the other 2 macronutrients unchanged from eucaloric baseline diet. Energy and macronutrient intake during the reduced energy diets are pres...
PMC10371234