Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis.

Introduction: Vulvar cancer carries a favourable prognosis in early stages. However, therapeutic options for advanced or recurrent cases are limited despite a variety of therapeutic modalities, such as extensive surgical resection, chemotherapy, and radiotherapy. The most important emerging treatment modalities are immune checkpoint inhibitors. This systematic review and meta-analysis aims to assess the efficacy and safety of pembrolizumab, an immune checkpoint inhibitor, in women with advanced vulvar cancer. Materials and methods: Following a comprehensive search, review, and appraisal, two relevant single-arm studies were included. Meta-analysis was conducted using R4.3.0 software and RStudio 2023.03.0, presenting the overall effect size with a 95% confidence interval. Heterogeneity was assessed using I2 and the Cochrane Q χ2 statistics. Results: Out of 154 studies screened for eligibility, two single-arm studies involving 119 patients receiving pembrolizumab for advanced vulvar cancer were included. The pooled objective response rate (ORR) was overall 10% (95% CI: 0.00-0.84) and 9% (95% CI: 0.00-0.89) in the PD-L1 positive subgroup. In the intention-to-treat (ITT) population, 31% (95% CI: 0.04-0.85) exhibited any clinical benefit (complete response, partial response, or stable disease). In the ITT population at six months, progression-free survival (PFS) was 19% (95% CI: 0.01-0.82), and overall survival (OS) was 48% (95% CI: 0.08-0.90). At 12 months, PFS decreased to 9% (95% CI: 0.00-0.85), and OS was 33% (95% CI: 0.04-0.85). No statistically significant heterogeneity was observed in PFS and OS analyses. Discussion and conclusion: This study suggests that one-third of women with advanced or recurrent vulvar cancer may, without the influence of PD-L1 status, benefit from pembrolizumab treatment despite a decline in both PFS and OS at 12 months. These findings provide support for considering pembrolizumab in the treatment paradigm for this specific subset of cancer patients. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42023391888.

Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial.

Fatigue is a very common side effect during intravenous chemotherapy. Unfortunately, only few effective therapeutic options are available, mostly based on daily activity. In our pilot trial we were able to demonstrate that intermittent fasting can reduce fatigue in healthy people, thus we aimed to assess the effects of the fasting dietary on quality of life during chemotherapy in patients with gynecological cancer, especially on the domain of fatigue. The IFAST trial is designed as a prospective, randomized-controlled, multi-center trial. Participation will be offered to women with gynecological cancers (breast cancer, ovarian cancer including peritoneal and fallopian tube cancers, endometrial cancer and cervical cancer) who are planned to receive intravenous chemotherapy for at least three months. Eligible patients will be randomized 1:1, stratified by tumor type and study center. Primary endpoint is the difference in mean change in fatigue, assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT- FS©). Exploratory secondary endpoints will include general Quality of Life impairment, tolerance of chemotherapy, immunological changes, peripheral cell damage in blood cells, as well as tumor response to chemotherapy. There is new evidence that prolonged fasting periods of 46-96 hours during chemotherapy can positively influence the quality of life during chemotherapy. However, these fasting regiments are not feasible for many patients. Intermittent fasting could be a feasible (manageable) option for many patients to actively improve their quality of life and tolerance to chemotherapy and possibly even enhance the effectiveness of chemotherapy. Trial Registration: https://drks.de, identifier DRKS00031429.

Real-World Experience of Metronomic Chemotherapy in Metastatic Breast Cancer: Results of a Retrospective Unicenter Study.

Introduction: Metronomic chemotherapy (MCT) is increasingly used in oncology due to its favorable therapeutic index. There is still a lack of evidence for MCT in metastatic breast cancer (MBC). In this retrospective unicenter study, we demonstrated real-word data on MCT in MBC. Methods: MBC patients who received metronomic oral cyclophosphamide (CTX) (50 mg daily) and methotrexate (MTX) (2.5 mg every other day), CTX and capecitabine (CAPE) (500 mg thrice daily), CTX, or vinorelbine (VRL) (30 mg daily) alone for at least 4 weeks between 2009 and 2021 were included. The primary endpoint was disease control rate (DCR) ≥24 weeks. Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Patient characteristics and therapy response were analyzed using χ2 test. For survival analyses, Kaplan-Meier estimator and log-rank test were used. Results: Seventy-two patients were identified. Sixty-two patients received CTX/MTX, three CTX/CAPE, two CTX, and five VRL. Median age at diagnosis MBC and at start of MCT was 59.0 years and 64.5 years, respectively. 72.2% tumors were hormone receptor positive and 27.8% were triple-negative. 54.2% patients had more than two different metastases. 80.6% patients showed visceral involvement. 31.9% patients achieved DCR ≥24 weeks. Median PFS was 17.0 weeks (95% CI 14.5-19.5) and median OS was 58.0 weeks (95% CI 29.0-87.0). MCT showed similar DCR ≥24 weeks and clinically meaningful but not statistically significant shorter median PFS compared to prior therapy (31.9% versus 32.8% [p = 0.570] and 17.0 weeks versus 20.0 weeks [p = 0.093], respectively) and statistically significant higher DCR ≥24 weeks and longer median PFS compared to subsequent therapy (31.9% versus 17.4% [p = 0.038] and 17.0 weeks versus 12.0 weeks [p = 0.006], respectively). Three (4.2%) patients terminated MCT because of toxicity. Conclusion: In this real-world retrospective study, MCT was effective and well tolerated and may thus represent a valuable treatment option in selected MBC patients.

Robotic-assisted versus laparoscopic bowel anastomoses: randomized crossover in vivo experimental study.

BACKGROUND: Initial learning curves are potentially shorter in robotic-assisted surgery (RAS) than in conventional laparoscopic surgery (LS). There is little evidence to support this claim. Furthermore, there is limited evidence how skills from LS transfer to RAS. METHODS: A randomized controlled, assessor blinded crossover study to compare how RAS naïve surgeons (n = 40) performed linear-stapled side-to-side bowel anastomoses in an in vivo porcine model with LS and RAS. Technique was rated using the validated anastomosis objective structured assessment of skills (A-OSATS) score and the conventional OSATS score. Skill transfer from LS to RAS was measured by comparing the RAS performance of LS novices and LS experienced surgeons. Mental and physical workload was measured with the NASA-task load index (NASA-Tlx) and the Borg-scale. OUTCOMES: In the overall cohort, there were no differences between RAS and LS for surgical performance (A-OSATS, time, OSATS). Surgeons that were naïve in both LS and RAS had significantly higher A-OSATS scores in RAS (Mean (Standard deviation (SD)): LS: 48.0 ± 12.1; RAS: 52.0 ± 7.5); p = 0.044) mainly deriving from better bowel positioning (LS: 8.7 ± 1.4; RAS: 9.3 ± 1.0; p = 0.045) and closure of enterotomy (LS: 12.8 ± 5.5; RAS: 15.6 ± 4.7; p = 0.010). There was no statistically significant difference in how LS novices and LS experienced surgeons performed in RAS [Mean (SD): novices: 48.9 ± 9.0; experienced surgeons: 55.9 ± 11.0; p = 0.540]. Mental and physical demand was significantly higher after LS. CONCLUSION: The initial performance was improved for RAS versus LS for linear stapled bowel anastomosis, whereas workload was higher for LS. There was limited transfer of skills from LS to RAS.

Video-based training of situation awareness enhances minimally invasive surgical performance: a randomized controlled trial.

BACKGROUND: Many training curricula were introduced to deal with the challenges that minimally invasive surgery (MIS) presents to the surgeon. Situational awareness (SA) is the ability to process information effectively. It depends on general cognitive abilities and can be divided into three steps: perceiving cues, linking cues to knowledge and understanding their relevance, and predicting possible outcomes. Good SA is crucial to predict and avoid complications and respond efficiently. This study aimed to introduce the concept of SA into laparoscopic training. METHODS: This is a prospective, randomized, controlled study conducted at the MIS Training Center of Heidelberg University Hospital. Video sessions showing the steps of the laparoscopic cholecystectomy (LC) were used for cognitive training. The intervention group trained SA with interposed questions inserted into the video clips. The identical video clips, without questions, were presented to the control group. Performance was assessed with validated scores such as the Objective Structured Assessment of Technical Skills (OSATS) during LC. RESULTS: 72 participants were enrolled of which 61 were included in the statistical analysis. The SA-group performed LC significantly better (OSATS-Score SA: 67.0 ± 11.5 versus control: 59.1 ± 14.0, p value = 0.034) and with less errors (error score SA: 3.5 ± 1.9 versus control: 4.7 ± 2.0, p value = 0.027). No difference in the time taken to complete the procedure was found. The benefit assessment analysis showed no difference between the groups in terms of perceived learning effect, concentration, or expediency. However, most of the control group indicated retrospectively that they believed they would have benefitted from the intervention. 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.

A questionnaire-based survey on the diagnostic and therapeutic approaches for patients with STIC in Germany.

PURPOSE: Despite the growing understanding of the carcinogenesis of pelvic high-grade serous carcinoma (HGSC) of the ovary and peritoneum and its precursor lesion serous tubal intraepithelial carcinoma (STIC), evidence-based proven recommendations on the clinical management of patients with STIC are lacking so far. METHODS: A questionnaire containing 21 questions was developed to explore the clinical experience with patients with the diagnosis of STICs and the diagnostic, surgical and histopathological approaches in Germany. Overall, 540 clinical heads of department in all German gynaecological centres were asked to participate. RESULTS: 131 questionnaires (response rate 24.3%) were included in this survey. 45.8% of the respondents had treated one to three STIC patients during their career. 75.6% of the respondents performed opportunistic bilateral salpingectomies during other gynaecological surgeries. Most of the participants (31.3%) started with the SEE-FIM (Sectioning and Extensively Examining the FIMbria) protocol in 2014. It was requested by 39.7% centres for prophylactic salpingectomies, by 13.7% for both prophylactic and opportunistic salpingectomies and by 22.1% for neither of both. 38.2%, 1.5% and 24.4% of the participants would use the laparoscopic, transverse and midline laparotomic approach for a surgical staging procedure, respectively. 25.6% (54.7%) of the respondents recommended a hysterectomy in premenopausal (versus postmenopausal) patients with a STIC, 24.4% (88.4%) a bilateral oophorectomy and 50.0% (4.7%) an affected side oophorectomy (all p values < 0.001). Omentectomy, pelvic and para-aortic lymphadenectomy would be performed by 60.5% (64.0%), 9.3% (11.6%) and 9.3% (11.6%) of respondents in premenopausal (versus postmenopausal) patients (all p values > 0.05). CONCLUSION: Our survey highlights significant inconsistency in the management of patients with STIC. Prospective data are urgently needed to elucidate the clinical impact of a STIC lesion and its clinical management.

The preoperative G8 geriatric screening tool independently predicts survival in older patients with endometrial cancer: results of a retrospective single-institution cohort study.

PURPOSE: The aim of this retrospective study was to evaluate the prognostic impact of global health status assessment tools in elderly patients with endometrial cancer (EC) on survival. METHODS: Preoperative frailty status was assessed by the G8 geriatric screening tool (G8 Score), Lee Schonberg prognostic index, Charlson Comorbidity index and American Society of Anesthesiologists Physical Status System in women older than 60 years with EC. Univariable and multivariable Cox-regression analyses, as well as Kaplan-Meier survival analyses were performed to determine the prognostic impact. Statistical analyses were adjusted for cancer entity-specific risk factors such as conventional histopathological tumor characteristics and relevant anamnestic life style parameters. RESULTS: 153 patients with all stages of EC who were operated at the University Medical Center Mainz between 2008 and 2019 were included. In multivariable analyses, only the G8 Score retained independent significance as a prognostic factor for disease-specific survival (DSS) (HR:4.58; 95% CI [1.35-15.51]) and overall survival (OS) (HR:2.89; 95% CI [1.31-6.39]. 92 patients (61.3%) were classified as G8-non-frail with a significantly increased DSS and OS rate compared to the 58 G8-frail patients (DSS:93.8% vs. 60.8%; p < 0.001 and OS:88.2% vs. 49.7%; p < 0.001; respectively). CONCLUSIONS: This is the first study demonstrates the substantial clinical and prognostic impact of the G8 Score on survival in elderly women with EC. Assessing the frailty status to estimate the individual vulnerability of elderly cancer patients could be useful in preoperative decision-making to individualize treatment plans such as the surgical radicality and to improve pre- and postoperative morbidity.

Frailty assessment tools predict perioperative outcome in elderly patients with endometrial cancer better than age or BMI alone: a retrospective observational cohort study.

OBJECTIVE: Five commonly used global health assessment tools have been evaluated to identify and assess the preoperative frailty status and its relationship with perioperative in-hospital complications and transfusion rates in older women with endometrial cancer (EC). METHODS: Preoperative frailty status was examined by the G8 questionnaire, the Eastern Cooperative Oncology Group performance status, the Charlson Comorbidity Index and the American Society of Anesthesiologists Physical Status System, as well as the Lee-Schonberg prognostic index. The main outcome measures were perioperative laboratory values, intraoperative surgical parameters and immediately postoperative complications. RESULTS: 153 consecutive women ≥ 60 years with all stages of EC, who received primary elective surgery at the University Medical Center Mainz between 2008 and 2019 were classified with selected global health assessment tools according to their preoperative performance status. In contrast to conventional prognostic parameters like older age and higher BMI, increasing frailty was significantly associated with preoperative anemia and perioperative transfusions (p < 0.05). Moreover, in patients preoperatively classified as frail significantly more postoperative complications (G8 Score: frail: 20.7% vs. non-frail: 6.7%, p = 0.028; ECOG: frail: 40.9% vs. non-frail: 2.8%, p = 0.002; and CCI: frail: 25.0% vs. non-frail: 7.4%, p = 0.003) and an increased length of hospitalization were recorded. According to propensity score matching, the risk for developing postoperative complications for frail patients was approximately two-fold higher, depending on which global health assessment tool was used. CONCLUSIONS: Preoperatively assessed frailty significantly predicts post-surgical morbidity rates in contrast to conventionally used single prognostic parameters such as age or BMI. A standardized preoperative assessment of frailty in the routine work-up might be beneficial in older cancer patients before major surgery to include these patients in a prehabilitation program with nutrition counseling and physiotherapy to adequately assess the perioperative risk.

Influence of interdisciplinary frailty screening on perioperative complication rates in elderly ovarian cancer patients: results of a retrospective observational study.

PURPOSE: Frailty is a frequent and underdiagnosed multidimensional age-related syndrome, involving decreased physiological performance reserves and marked vulnerability against major stressors. To standardize the preoperative frailty assessment and identify patients at risk of adverse surgical outcomes, commonly used global health assessment tools were evaluated. We aimed to assess three interdisciplinary preoperative screening assessments to investigate the influence of frailty status with in-hospital complications irrespective of surgical complexity and radicality in older women with ovarian cancer (OC). METHODS: Preoperative frailty status was examined by the G8 geriatric screening tool (G8 Score-geriatric screening), Eastern Cooperative Oncology Group performance status (ECOG PS-oncological screening), and American Society of Anesthesiologists Physical Status System (ASA PS-anesthesiologic screening). The main outcome measures were the relationship between perioperative laboratory results, intraoperative surgical parameters and the incidence of immediate postoperative in-hospital complications with the preoperative frailty status. RESULTS: 116 consecutive women 60 years and older (BMI 24.8 ± 5.2 kg/m2) with OC, who underwent elective oncological surgery in University Medical Center Mainz between 2008 and 2019 were preoperatively classified with the selected global health assessment tools as frail or non-frail. The rate of preoperative anemia (hemoglobin ≤ 12 g/dl) and perioperative transfusions were significantly higher in the G8-frail group (65.9% vs. 34.1%; p = 0.006 and 62.7% vs. 41.8%, p = 0.031; respectively). In addition, patients preoperatively classified as G8-frail exhibited significantly more postoperative clinical in-hospital complications (27.8% vs. 12.5%, p = 0.045) independent of chronological age and BMI. In contrast, ECOG PS and ASA PS did not predict the rates of postoperative complications (all p values > 0.05). After propensity score matching, the complication rate in the G8-frail cohort was approximately 1.7 times more common than in the G8-non-frail cohort. CONCLUSION: Preoperative frailty assessment with the G8 Score identified elderly women with OC recording a significantly higher rate of postoperative in-hospital complications. In G8-frail patients, preoperative anemia and perioperative transfusions were significantly more recorded, regardless of chronological age, abnormal BMI and surgical complexity. Standardized preoperative frailty assessment should be added to clinical routine care to enhance risk stratification in older cancer individuals for surgical patient-centered decision-making.

Influence of anesthetic technique on survival after tumor debulking surgery of elderly patients with ovarian cancer: Results of a retrospective cohort study.

Epidural analgesia could influence the postoperative oncologic outcomes in patients with specific types of non-metastatic solid neoplasms. The present study aimed to investigate the impact of anesthetic technique on survival in elderly patients with ovarian cancer (OC). The records of all women with OC older than 60 years of age undergoing tumor debulking surgery at the University Medical Center of the Johannes Gutenberg University Mainz (Mainz, Germany) between January 2008 and December 2019 were obtained. The study cohort was divided into two groups based on the use of perioperative epidural anesthesia or not. First, Kaplan-Meier analysis was performed to analyze the prognostic influence of anesthetic technique on survival. Second, multivariate Cox proportional hazards model was adjusted for multiple conventional prognostic factors concerning three main categories: i) Current clinical-pathological tumor characteristics; ii) anesthesiologic parameters, including mean age, American Society of Anesthesiologists Performance Status and preexisting comorbidities summarized in the Charlson Comorbidity Index; and iii) oncological and surgical parameters such as oncological radicality and Surgical complexity Score. A total of 110 patients were included in the study and 71 (64.5%) of them received epidural analgesia. The median survival time was 26.0 months from primary debulking surgery and no significant differences in progression-free (PFS) and overall survival (OS) were noted between the 'Epidural' and 'non-Epidural' cohorts. After adjustment for the selected risk factors from the three categories, the effects of epidural analgesia on PFS and OS remained non-significant [PFS: hazard ratio (HR), 1.26; 95% CI, 0.66-2.39; and OS: HR, 0.79; 95% CI, 0.45-1.40]. The present results did not support the independent association between epidural-supplemented anesthesia and improved PFS or OS in elderly patients with standardized ovarian cancer debulking surgery.

Impact of perioperative red blood cell transfusion, anemia of cancer and global health status on the prognosis of elderly patients with endometrial and ovarian cancer.

Introduction: Perioperative red blood cell (RBC) transfusions have been associated with increased morbidity and worse oncological outcome in some solid neoplasms. In order to elucidate whether RBC transfusions themselves, the preoperative anemia of cancer (AOC), or the impaired global health status might explain this impact on patients with endometrial cancer (EC) or ovarian cancer (OC), we performed a retrospective, single-institution cohort study. Materials and methods: Women older than 60 years with EC or OC were included. The influence of RBC transfusions, AOC, and frailty status determined by the G8 geriatric screening tool (G8 score), as well as the clinical-pathological cancer characteristics on progression-free survival (PFS) and overall survival (OS), was determined by using the Kaplan-Meier method and the Cox regression analyses. Results: In total, 263 patients with EC (n = 152) and OC (n = 111) were included in the study. Patients with EC receiving RBC transfusions were faced with a significantly shorter 5-year PFS (79.8% vs. 26.0%; p < 0.001) and 5-year OS (82.6% vs. 25.7%; p < 0.001). In multivariable analyses, besides established clinical-pathological cancer characteristics, the RBC transfusions remained the only significant prognostic parameter for PFS (HR: 1.76; 95%-CI [1.01-3.07]) and OS (HR: 2.38; 95%-CI [1.50-3.78]). In OC, the G8 score stratified the cohort in terms of PFS rates (G8-non-frail 53.4% vs. G8-frail 16.7%; p = 0.010) and AOC stratified the cohort for 5-year OS estimates (non-anemic: 36.7% vs. anemic: 10.6%; p = 0.008). Multivariable Cox regression analyses determined the G8 score and FIGO stage as independent prognostic factors in terms of PFS (HR: 2.23; 95%-CI [1.16-4.32] and HR: 6.52; 95%-CI [1.51-28.07], respectively). For OS, only the TNM tumor stage retained independent significance (HR: 3.75; 95%-CI [1.87-7.53]). Discussion: The results of this trial demonstrate the negative impact of RBC transfusions on the prognosis of patients with EC. Contrastingly, the prognosis of OC is altered by the preoperative global health status rather than AOC or RBC transfusions. In summary, we suggested a cumulatively restrictive transfusion management in G8-non-frail EC patients and postulated a more moderate transfusion management based on the treatment of symptomatic anemia without survival deficits in OC patients.

Predictors of Psychological Distress in Women with Endometriosis during the COVID-19 Pandemic.

Background: Endometriosis is a multifaceted chronic pain condition that can have a negative impact on mental health. Patients suffering from chronic pain may face an additional psychological burden during adversity, such as the COVID-19 pandemic. The main aim of this research was to evaluate the prevalence of self-reported depression and anxiety, the influence of demographic, endometriosis-specific, pandemic-specific factors, and resilience on mental health outcomes of patients with endometriosis. Methods: An online survey was conducted through patient support groups of women suffering from endometriosis during the first wave of the COVID-19 pandemic. The PHQ-4 questionnaire, which combines two items of the Patient Health Questionnaire for Depression (PHQ-2) and two items from the Generalized Anxiety Disorder Scale (GAD-2) was used to assess self-reported mental health. The Brief Resilience Score (BRS) was employed to evaluate resilience. Independent risk and protective factors for mental health were investigated by multivariate logistic regression analyses. Results: The PHQ-4 questionnaire was completed by 274 respondents. More than 40% reached depression (PHQ-2) and anxiety (GAD-2) scores of ≥3, and more than 20% achieved PHQ-2 and GAD-2 scores of ≥5. High resilience was found to be a reliable and strong independent protector for the probability of developing adverse psychological outcomes: OR 0.295, p < 0.001 for developing generalized anxiety disorder (GAD-2 ≥ 3), and OR 0.467, p < 0.001 for having major depression (PHQ-2 ≥ 3). Conclusions: Pain-induced disability is an independent risk factor for developing major depression and anxiety, while resilience was identified as a potential protective parameter in terms of positive psychological outcomes in women with endometriosis. The results of this study may help to identify women at risk for adverse mental health outcomes and should encourage healthcare practitioners to establish strategies for the reduction of negative psychological and psychiatric impacts on patients with endometriosis.

G-8 Geriatric Screening Tool Independently Predicts Progression-Free Survival in Older Ovarian Cancer Patients Irrespective of Maximal Surgical Effort: Results of a Retrospective Cohort Study.

BACKGROUND: We evaluated the prognostic impact of various global health assessment tools in patients older than 60 years with ovarian cancer (OC). METHODS: G-8 geriatric screening tool (G-8 score), Lee Schonberg prognostic index, Eastern Cooperative Oncology Group (ECOG) performance status, and Charlson Comorbidity Index (CCI) were determined retrospectively in a consecutive cohort of elderly patients with OC. Univariate and multivariate Cox regression analyses and Kaplan-Meier method were performed to analyze the impact of the preoperative global health status on survival. RESULTS: 116 patients entered the study. In multivariate analysis adjusted for clinical-pathological factors, only the G-8 score retained significance as a prognostic parameter of progression-free survival (PFS) (hazard ratio [HR]: 1.970; 95% confidence interval [CI] [1.056-3.677]; p = 0.033). Fifty-six patients were classified as G-8-nonfrail with an increased PFS compared to 50 G-8-frail patients (53.4% vs. 16.7%; p = 0.010). A higher CCI was associated with decreased PFS (45.1% vs. 22.2%; p = 0.012), but it did not influence the risk of recurrences or death (p = 0.360; p = 0.111). The Lee Schonberg prognostic index, the ECOG, and age were not associated with survival. CONCLUSIONS: The G-8 score independently predicted PFS in elderly OC patients regardless of maximal surgical effort. Thus, it could be useful to assess surgical treatment based on frailty rather than age alone.

[New Approaches for Young Surgeons - Students' Symposium on Minimally Invasive Surgery]. / Neue Wege zum chirurgischen Nachwuchs ­ Studierendenforum für Minimal Invasive Chirurgie.

Background Physician shortage is particularly striking in surgical specialities. Umbrella organisations are making an effort to recruit medical students. Students' symposia during congresses seem to provide a promising approach to developing motivation and promoting interest. An exemplary students' symposium took place at the three nations meeting for minimally invasive surgery (MIS). Our aim was to evaluate the students' symposium from the students' perspective, in order to give recommendations for the future. Methods Of a total of 60 participants, half (30/60) completed the survey. Using a 5-point Likert scale, students evaluated items on the agenda, increase in interests, personal benefit and likelihood of future participation. Results Sixty percent (18/30) of the participants in the student forum reported enhanced interest in MIC - the largest increase found. For surgery in general and for robotic surgery in particular, an increase was reported by 57% (17/30) of the students. Of all the items on the agenda, laparoscopic hands-on experience was rated best - with a positive rating from 90% (27/30) of the students. Students expressed the wish for improved personal exchange with experts and professionals. Two thirds (40/60) of the students stated that future participation was definite or very likely. Discussion The increase in interest in MIS and surgery in general demonstrated the success of the students' symposium. Hands-on experiences was very popular. Future events should focus on personal exchange between students and experts. This seems necessary to reduce prejudice in the debate on a well-adjusted work-life balance. With a view to physician shortage in surgical specialties, students' symposia are a valuable option that should be firmly established and consistently developed.

Does rating the operation videos with a checklist score improve the effect of E-learning for bariatric surgical training? Study protocol for a randomized controlled trial.

BACKGROUND: Laparoscopic training has become an important part of surgical education. Laparoscopic Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed. Surgeons must be well trained prior to operating on a patient. Multimodality training is vital for bariatric surgery. E-learning with videos is a standard approach for training. The present study investigates whether scoring the operation videos with performance checklists improves learning effects and transfer to a simulated operation. METHODS/DESIGN: This is a monocentric, two-arm, randomized controlled trial. The trainees are medical students from the University of Heidelberg in their clinical years with no prior laparoscopic experience. After a laparoscopic basic virtual reality (VR) training, 80 students are randomized into one of two arms in a 1:1 ratio to the checklist group (group A) and control group without a checklist (group B). After all students are given an introduction of the training center, VR trainer and laparoscopic instruments, they start with E-learning while watching explanations and videos of RYGB. Only group A will perform ratings with a modified Bariatric Objective Structured Assessment of Technical Skill (BOSATS) scale checklist for all videos watched. Group B watches the same videos without rating. Both groups will then perform an RYGB in the VR trainer as a primary endpoint and small bowel suturing as an additional test in the box trainer for evaluation. DISCUSSION: This study aims to assess if E-learning and rating bariatric surgical videos with a modified BOSATS checklist will improve the learning curve for medical students in an RYGB VR performance. This study may help in future laparoscopic and bariatric training courses. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00010493 . Registered on 20 May 2016.

Learning from the surgeon's real perspective - First-person view versus laparoscopic view in e-learning for training of surgical skills? Study protocol for a randomized controlled trial.

BACKGROUND: Surgical proficiency is highly dependent on continuous and efficient training. However, efficacy of training hinges on questions such as accessibility and how intuitively the training can be translated into reality. Minimally invasive surgery (MIS) in particular relies on adequate training modalities in order to compensate for its additional psychomotor and visuospatial challenges. The increasing demand for MIS procedures longs for further enhancement of training and steep learning curves. We are investigating a nouveau training concept that continuously utilizes the first person view as addendum to laparoscopic view. We hypothesize this approach to be more intuitive thus faster and more naturally to apprehend than a laparoscopic view only and aim to establish a new standard to implement into training curricula. METHODS AND ANALYSIS: The present study is conducted as a monocentric, two-arm randomized trial. Participants undergo a training curriculum in laparoscopic suturing and knot tying, using e-learning video material with either the first-person perspective of the surgeon or the laparoscopic view only. Primary endpoint is the total training time needed to reach a predefined proficiency level. Participants are evaluated by blinded raters using validated checklists. Number of attempts, procedure and knot quality subscore difference as well as metric parameter analysis from the first and last knots analyzed as secondary endpoints. Furthermore, trainees are assessed with regard to surgical background, basic skills level and spatial awareness. A total sample size of 80 participants for the analysis of the primary endpoint was determined, which will be performed as a two-sided t-test. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Ethics Committee of the Medical Faculty at Heidelberg University (Code S-334/2011). This trial was registered with the German Clinical Trials Register (DRKS) in Freiburg, Germany, on May 6th (DRKS00009997). The results will be published and presented at appropriate conferences.