Bariatric surgery for spontaneous ovulation in women living with polycystic ovary syndrome: the BAMBINI multicentre, open-label, randomised controlled trial.

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. Obesity exacerbates the reproductive complications of PCOS; however, the management of obesity in women with PCOS remains a large unmet clinical need. Observational studies have indicated that bariatric surgery could improve the rates of ovulatory cycles and prospects of fertility; however, the efficacy of surgery on ovulation rates has not yet been compared with behavioural modifications and medical therapy in a randomised trial. The aim of this study was to compare the safety and efficacy of bariatric surgery versus medical care on ovulation rates in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. METHODS: In this multicentre, open-label, randomised controlled trial, 80 women older than 18 years, with a diagnosis of PCOS based on the 2018 international evidence-based guidelines for assessing and managing PCOS, and a BMI of 35 kg/m2 or higher, were recruited from two specialist obesity management centres and via social media. Participants were randomly assigned at a 1:1 ratio to either vertical sleeve gastrectomy or behavioural interventions and medical therapy using a computer-generated random sequence (PLAN procedure in SAS) by an independent researcher not involved with any other aspect of the clinical trial. The median age of the entire cohort was 31 years and 79% of participants were White. The primary outcome was the number of biochemically confirmed ovulatory events over 52 weeks, and was assessed using weekly serum progesterone measurements. The primary endpoint included the intention-to-treat population and safety analyses were per-protocol population. This study is registered with the ISRCTN registry (ISRCTN16668711). FINDINGS: Participants were recruited from Feb 20, 2020 to Feb 1, 2021. 40 participants were assigned to each group and there were seven dropouts in the medical group and ten dropouts in the surgical group. The median number of ovulations was 6 (IQR 3·5-10·0) in the surgical group and 2 (0·0-4·0) in the medical group. Women in the surgical group had 2.5 times more spontaneous ovulations compared with the medical group (incidence rate ratio 2·5 [95% CI 1·5-4·2], p<0·0007). There were more complications in the surgical group than the medical group, although without long-term sequelae. There were 24 (66·7%) adverse events in the surgical group and 12 (30·0%) in the medical group. There were no treatment-related deaths. INTERPRETATION: Bariatric surgery was more effective than medical care for the induction of spontaneous ovulation in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. Bariatric surgery could, therefore, enhance the prospects of spontaneous fertility in this group of women. FUNDING: The Jon Moulton Charity Trust.

Adipositas Care and Health Therapy (ACHT) after Bariatric-Metabolic Surgery: A Prospective, Non-Randomized Intervention Study.

INTRODUCTION: Almost 25% of German adults have obesity and numbers are rising, making it an important health issue. Bariatric-metabolic surgery reduces body weight and complications for persons with obesity, but therapeutic success requires long-term postoperative care. Since no German standards for follow-up by family physicians exist, follow-up is provided by surgical obesity centers, but they are reaching their limits. The ACHT study, funded by the German Innovation Fund, is designed to establish and evaluate the follow-up program, with local physicians following patients supported remotely by obesity centers. METHODS: ACHT is a multicenter, prospective, non-randomized control group study. The 18-month ACHT follow-up program is a digitally supported, structured, cross-sectoral, and close-to-home program to improve success after bariatric-metabolic surgery. Four groups are compared: intervention group 1 starts the program immediately (3 weeks) after Roux-en-Y gastric bypass or sleeve gastrectomy (months 1-18 postoperatively), intervention group 2 begins the program 18 months after surgery (months 19-36 postoperatively). Intervention groups are compared to respective control groups that had surgery 18 and 36 months previously. In total, 250 patients, enrolled in the intervention groups, are compared with 360 patients in the control groups, who only receive standard care. RESULTS: The primary endpoint to compare intervention and control groups is the adapted King's score, a composite tool evaluating physical, psychological, socioeconomic, and functional health status. Secondary endpoints include changes in care structures and care processes for the intervention groups. Multivariate regression analyses adjusting for confounders (including the type of surgery) are used to compare intervention and control groups and evaluate determinants in longitudinal analyses. The effect of the intervention on healthcare costs will be evaluated based on health insurance billing data of patients who had bariatric-metabolic surgery in the 3 years prior to the start of the study and of patients who undergo bariatric-metabolic surgery during the study period. CONCLUSIONS: ACHT will be the one of the first evaluated structured, close-to-home follow-up programs for bariatric surgery in Germany. It will evaluate the effectiveness of the implemented program regarding improvements in health status, mental health, quality of life, and the feasibility of such a program outside of specialized obesity centers.

Psychometric properties of the WBIS/-M in a representative prebariatric sample - evidence for an improved 10-item version.

Introduction The Weight Bias Internalization Scale and the Modified Weight Bias Internalization Scale are well-established self-report questionnaires for assessing weight bias internalization, which is widespread among bariatric patients. However, among this group, psychometric properties of the Weight Bias Internalization Scale have only been examined in small samples showing unsatisfactory model fit and have not been explored for the modified questionnaire. Methods This study psychometrically evaluated and compared the Weight Bias Internalization Scale and Modified Weight Bias Internalization Scale in a large sample of prebariatric patients (N=825, mean age=46.75 years, SD=11.55) regarding item characteristics, model fit to unidimensionality, reliability, construct validity, and measurement invariance. Results Item 4 of both questionnaires showed low corrected item-total correlations (<.40) and was therefore removed from the scales. The new 10-item versions showed improved item characteristics, internal consistency, model fit to unidimensionality, and convergent and divergent validity when compared to the 11-item versions. The best psychometric properties were found for the 10-item version of the Modified Weight Bias Internalization Scale. Conclusion The 10-item version of the Modified Weight Bias Internalization Scale surpasses the other versions studied in all psychometric properties. Therefore, it should be used in prebariatric patients to detect weight bias internalization and provide them with psychological interventions that could improve bariatric surgery outcomes.

Depressive Symptoms among Bariatric Surgery Candidates: Associations with Stigmatization and Weight and Shape Concern.

Bariatric surgery candidates (BSC) are a highly vulnerable group for mental health impairments. According to the theoretical model of weight stigma, weight-related experienced stigmatization (ES) negatively influences mental health through weight bias internalization (WBI). This study tested this model among BSC and investigated whether this association depends on a negative body image in terms of weight and shape concern as a potential moderator. As part of a German multicenter study, ES, WBI, weight and shape concern, and depressive symptoms were assessed via self-report questionnaires among n = 854 BSC. Simple and moderated mediation analyses were applied to analyze whether WBI influences the relationship between ES and depressive symptoms, and whether this influence depends on weight and shape concern. WBI significantly mediated the relationship between ES and depressive symptoms by partially reducing the association of ES with depressive symptoms. Weight and shape concern emerged as significant moderators in the overall model and specifically for associations between WBI and depressive symptoms. The results suggest that the association between ES and depressive symptoms among BSC is stronger in those with high WBI. This association is strengthened by weight and shape concern, especially at low and mean levels. Studies evaluating longitudinal associations between weight-related stigmatization and mental health are indicated, as well as intervention studies targeting WBI in order to reduce adverse effects of ES on mental health in BSC.

Clinical Management of Major Postoperative Bleeding After Bariatric Surgery.

INTRODUCTION: Major postoperative bleeding (mPOB) is the most common complication after bariatric surgery. Its intesity varies from self-limiting to life-threatening situations. Comprehensive decision-making and treatment strategies are mandatory but not established yet. METHODS: We retrospectively analyzied our prospectively collected database of our bariatric patients during 2012-2022. The primary study endpoint was major postoperative bleeding (mPOB) defined as hemoglobin drop > 2 g/dl or clinically relevant bleeding requiring intervention (transfusion, endoscopy or surgery). Secondary endpoints were overall complications according to Clavien-Dindo-Classification and comprehensive-complication-index (CCI). RESULTS: We identified 1017 patients, of whom 667 underwent gastric bypass (GB) and 350 sleeve gastrectomy (SG). Major postoperative bleeding occured in 39 patients (total 3.8%; 5.1% after GB and 2.3% after SG). Patients with mPOB were more often diagnosed with type 2 diabetes (p = 0.039), chronic kidney failure (p = 0.013) or received antiplatelet drug treatment (p = 0.003). The interval from detection to intervention within 24 h was 92.1% (35/39). Blood transfusions were necessary in 20/39 cases (total 51.3%; 45.2% after GB and 75% after SG; p = 0.046). Luminal bleeding only occured after GB (19/31; 61.3%), while all mPOB after SG were intraabdominal (p = 0.002). Reoperations were performed in 21/39 (total 53.8%; 48.4% after GB and 75% after SG; p = 0.067). CCI in patients with mPOB was 34.7 overall, with 31.2 after GB and 47.9 after SG (p = 0.005). CONCLUSION: The clinical appearance of mPOB depends on the type of surgery with severe bleedings after SG. We suggest a surgery first approach for mPOB after SG and an endoscopy first approach after GB.

Surgical treatment of internal hernia after Roux-en-Y gastric bypass - impact of institutional standards and surgical approach.

INTRODUCTION: Internal hernia is one of the most frequent long-term complications after laparoscopic gastric bypass surgery (RYGB). Surgical treatment of an internal hernia itself has risks that can largely be avoided by the implementation of institutional standards and a structured approach. MATERIAL AND METHODS: From 2012 until 2022, we extracted all consecutive bariatric cases from the prospectively collected national database (StuDoQ). Data from all patients undergoing internal hernia repair were then collected from our hospital information management system and retrospectively analyzed. We compared patient characteristics and surgical outcome of patients before and after the implementation of standard operating procedures for institutional and perioperative aspects (first vs. second time span). RESULTS: Overall, 37 patients were identified (median age 43 years, 86.5% female). Internal hernia was diagnosed after substantial weight loss (17.2 kg/m2) and on average about 34 months after RYGB. Baseline characteristics (age, sex, BMI, achieved total weight loss% and time interval to index surgery were comparable between the two groups). After local standardization, the conversion rate decreased from 52.6 to 5.6% (p = 0.007); duration of surgery from 92 to 39 min (p = 0.003), and length of stay from 7.7 to 2.8 days (p = 0.019). CONCLUSION: In this study, we could demonstrate that the surgical therapy of internal hernia after gastric bypass can be significantly improved by implementing institutional and surgical standards. The details described (including a video) may provide valuable information for non-specialized surgeons to avoid pitfalls and improve surgical outcomes.

Effect of bariatric surgery on cardio-psycho-metabolic outcomes in severe obesity: A randomized controlled trial.

OBJECTIVE: Randomized evidence comparing the cardiovascular effects of surgical and conservative weight management is lacking. PATIENTS & METHODS: In this single-center, open-label randomized trial, obese patients with indication for Roux-en-Y gastric bypass (RYGB) and able to perform treadmill cardiopulmonary exercise testing (CPET) were included. After a 6-12 month run-in phase of multimodal anti-obesity treatment, patients were randomized to RYGB or psychotherapy-enhanced lifestyle intervention (PELI) and co-primary endpoints were assessed 12 months later. Thereafter, PELI patients could opt for surgery and patients were reassessed 24 months after randomization. Co-primary endpoints were mean change (95 % confidence intervals) in peak VO2 (ml/min/kg body weight) in CPET and the physical functioning scale (PFS) of the Short Form health survey (SF-36). RESULTS: Of 93 patients entering the study, 60 were randomized. Among these (median age 38 years; 88 % women; mean BMI 48·2 kg/m2), 46 (RYGB: 22 and PELI: 24) were evaluated after 12 months. Total weight loss was 34·3 % after RYGB vs. 1·2 % with PELI, while peak VO2 increased by +4·3 ml/min/kg (2·7, 5·9) vs +1·1 ml/min/kg (-0·2, 2·3); p < 0·0001. Respective improvement in PFS score was +40 (30, 49) vs +10 (1, 15); p < 0·0001. 6-minute walking distance also favored the RYGB group: +44 m (17, 72) vs +6 m (-14, 26); p < 0·0001. Left ventricular mass decreased after RYGB, but not with PELI: -32 g (-46, -17) vs 0 g (-13,13); p < 0·0001. In the non-randomized follow-up, 34 patients were assessed. Favorable changes were sustained in the RYGB group and were repeated in the 15 evaluated patients that opted for surgery after PELI. CONCLUSIONS: Among adults with severe obesity, RYGB in comparison to PELI resulted in improved cardiopulmonary capacity and quality of life. The observed effect sizes suggest that these changes are clinically relevant.

Gut Microbiota Contribution to Weight-Independent Glycemic Improvements after Gastric Bypass Surgery.

Roux-en-Y gastric bypass surgery (RYGB) leads to improved glycemic control in individuals with severe obesity beyond the effects of weight loss alone. Here, We addressed the potential contribution of gut microbiota in mediating this favourable surgical outcome by using an established preclinical model of RYGB. 16S rRNA sequencing revealed that RYGB-treated Zucker fatty rats had altered fecal composition of various bacteria at the phylum and species levels, including lower fecal abundance of an unidentified Erysipelotrichaceae species, compared with both sham-operated (Sham) and body weight-matched to RYGB-treated (BWM) rats. Correlation analysis further revealed that fecal abundance of this unidentified Erysipelotrichaceae species linked with multiple indices of glycemic control uniquely in RYGB-treated rats. Sequence alignment of this Erysipelotrichaceae species identified Longibaculum muris to be the most closely related species, and its fecal abundance positively correlated with oral glucose intolerance in RYGB-treated rats. In fecal microbiota transplant experiments, the improved oral glucose tolerance of RYGB-treated compared with BWM rats could partially be transferred to recipient germfree mice, independently of body weight. Unexpectedly, providing L. muris as a supplement to RYGB recipient mice further improved oral glucose tolerance, while administering L. muris alone to chow-fed or Western style diet-challenged conventionally raised mice had minimal metabolic impact. Taken together, our findings provide evidence that the gut microbiota contributes to weight loss-independent improvements in glycemic control after RYGB and demonstrate how correlation of a specific gut microbiota species with a host metabolic trait does not imply causation. IMPORTANCE Metabolic surgery remains the most effective treatment modality for severe obesity and its comorbidities, including type 2 diabetes. Roux-en-Y gastric bypass (RYGB) is a commonly performed type of metabolic surgery that reconfigures gastrointestinal anatomy and profoundly remodels the gut microbiota. While it is clear that RYGB is superior to dieting when it comes to improving glycemic control, the extent to which the gut microbiota contributes to this effect remains untested. In the present study, we uniquely linked fecal Erysipelotrichaceae species, including Longibaculum muris, with indices of glycemic control after RYGB in genetically obese and glucose-intolerant rats. We further show that the weight loss-independent improvements in glycemic control in RYGB-treated rats can be transmitted via their gut microbiota to germfree mice. Our findings provide rare causal evidence that the gut microbiota contributes to the health benefits of metabolic surgery and have implications for the development of gut microbiota-based treatments for type 2 diabetes.

[Pharmacotherapy of obesity-Competition to bariatric surgery or a meaningful supplement?] / Medikamentöse Therapie der Adipositas ­ Konkurrenz zur bariatrischen Chirurgie oder sinnvolle Ergänzung?

Obesity is a complex chronic disease and requires a long-term multimodal approach. The current treatment algorithm for treatment of obesity mainly consists of a stepwise approach, which starts with a lifestyle intervention followed by or combined with medication treatment, whereas bariatric surgery is often reserved for the last option. This article provides an overview of the currently available conservative medicinal treatment regimens and the currently approved medications as well as medications currently undergoing approval studies with respect to the efficacy and possible side effects. Special attention is paid to the importance of combination treatment of pharmacotherapy and surgery in the sense of a multimodal treatment. The data so far show that using a multimodal approach an improvement in the long-term weight loss and metabolic benefits can be achieved for the patients.

Endoscopic vacuum therapy as a first-line treatment option for gastric leaks after bariatric surgery: evidence from 10 years of experience.

BACKGROUND: Gastric (anastomotic or staple-line) leaks after bariatric surgery are rare but potentially life-threatening complications. Endoscopic vacuum therapy (EVT) has evolved as the most promising treatment strategy for leaks associated with upper gastrointestinal surgery. OBJECTIVE: The aim of this study was to evaluate the efficiency of our gastric leak management protocol in all bariatric patients over a 10-year period. Special emphasis was placed on EVT treatment and its outcome as a primary treatment or as a secondary treatment when other approaches failed. SETTING: This study was performed at a tertiary clinic and certified center of reference for bariatric surgery. METHODS: In this retrospective single-center cohort study, clinical outcomes of all consecutive patients after bariatric surgery from 2012 to 2021 are reported, with special emphasis placed on gastric leak treatment. The primary endpoint was successful leak closure. Secondary endpoints were overall complications (Clavien-Dindo classification) and length of stay. RESULTS: A total of 1046 patients underwent primary or revisional bariatric surgery, of whom 10 (1.0%) developed a postoperative gastric leak. Additionally, 7 patients were transferred for leak management after external bariatric surgery. Of these, 9 patients underwent primary and 8 patients underwent secondary EVT after futile surgical or endoscopic leak management. The efficacy of EVT was 100%, and there were no deaths. Complications did not differ between primary EVT and secondary treatment of leaks. Length of treatment was 17 days for primary EVT versus 61 days for secondary EVT (P = .015). CONCLUSIONS: EVT for gastric leaks after bariatric surgery led to rapid source control with a 100% success rate both as primary and secondary treatment. Early detection and primary EVT shortened treatment time and length of stay. This study underlines the potential of EVT as a first-line treatment strategy for gastric leaks after bariatric surgery.

Gastric bypass surgery weight loss-independently induces gut Il-22 release in association with improved glycemic control in obese Zucker fatty rats.

Background: Roux-en-Y gastric bypass surgery (RYGB) improves glycemic control in individuals with severe obesity beyond the effects of weight loss alone. To identify potential underlying mechanisms, we asked how equivalent weight loss from RYGB and from chronic caloric restriction impact gut release of the metabolically beneficial cytokine interleukin-22 (Il-22). Methods: Obese male Zucker fatty rats were randomized into sham-operated (Sham), RYGB, and sham-operated, body weight-matched to RYGB (BWM) groups. Food intake and body weight were measured regularly for 4 weeks. An oral glucose tolerance test (OGTT) was performed on postoperative day 27. Portal vein plasma, systemic plasma, and whole-wall samples from throughout the gut were collected on postoperative day 28. Gut Il-22 mRNA expression was determined by real-time quantitative PCR. Plasma Il-22 levels were determined by enzyme-linked immunosorbant assay (ELISA). Results: RYGB and BWM rats had lower food intake and body weight as well as superior blood glucose clearing capability compared with Sham rats. RYGB rats also had superior blood glucose clearing capability compared with BWM rats despite having similar body weights and higher food intake. Il-22 mRNA expression was approximately 100-fold higher specifically in the upper jejunum in RYGB rats compared with Sham rats. Il-22 protein was only detectable in portal vein (34.1 ± 9.4 pg/mL) and systemic (46.9 ± 10.5 pg/mL) plasma in RYGB rats. Area under the curve of blood glucose during the OGTT, but not food intake or body weight, negatively correlated with portal vein and systemic plasma Il-22 levels in RYGB rats. Conclusions: These results suggest that induction of gut Il-22 release might partly account for the weight loss-independent improvements in glycemic control after RYGB, and further support the use of this cytokine for the treatment of metabolic disease.

Volume-outcome relationship in adrenal surgery from 2009-2017 in Germany-a retrospective study.

OBJECTIVE: Adrenal resections are rare procedures of a heterogeneous nature. While recent European guidelines advocate a minimum annual caseload for adrenalectomies (6 per surgeon), evidence for a volume-outcome relationship for this surgery remains limited. DESIGN: A retrospective analysis of all adrenal resections in Germany between 2009 and 2017 using hospital billing data was performed. Hospitals were grouped into three tertiles of approximately equal patient volume. METHODS: Descriptive, univariate, and multivariate analyses were applied to identify a possible volume-outcome relationship (complications, complication management, and mortality). RESULTS: Around 17 040 primary adrenal resections were included. Benign adrenal tumors (n = 8,213, 48.2%) and adrenal metastases of extra-adrenal malignancies (n = 3582, 21.0%) were the most common diagnoses. Six hundred and thirty-two low-volume hospitals performed an equal number of resections as 23 high-volume hospitals (median surgeries/hospital/year 3 versus 31, P < .001). Complications were less frequent in high-volume hospitals (23.1% in low-volume hospitals versus 17.3% in high-volume hospitals, P < .001). The most common complication was bleeding in 2027 cases (11.9%) with a mortality of 4.6% (94 patients). Overall in-house mortality was 0.7% (n = 126). Age, malignancy, an accompanying resection, complications, and open surgery were associated with in-house mortality. In univariate analysis, surgery in high-volume hospitals was associated with lower mortality (OR: 0.47, P < .001). In a multivariate model, the tendency remained equal (OR: 0.59, P = .104). Regarding failure to rescue (death in case of complications), there was a trend toward lower mortality in high-volume hospitals. CONCLUSIONS: The annual caseload of adrenal resections varies considerably among German hospitals. Our findings suggest that surgery in high-volume centers is advantageous for patient outcomes although fatal complications are rare.

Hypothalamic integrity is necessary for sustained weight loss after bariatric surgery: A prospective, cross-sectional study.

OBJECTIVE: The hypothalamus is the main integrator of peripheral and central signals in the control of energy homeostasis. Its functional relevance for the effectivity of bariatric surgery is not entirely elucidated. Studying the effects of bariatric surgery in patients with hypothalamic damage might provide insight. SUMMARY BACKGROUND DATA: Prospective study to analyze the effects of bariatric surgery in patients with hypothalamic obesity (HO) vs. matched patients with common obesity (CO) with and without bariatric surgery. METHODS: 65 participants were included (HO-surgery: n = 8, HO-control: n = 10, CO-surgery: n = 12, CO-control: n = 12, Lean-control: n = 23). Body weight, levels of anorexic hormones, gut microbiota, as well as subjective well-being/health status, eating behavior, and brain activity (via functional MRI) were evaluated. RESULTS: Patients with HO lost significantly less weight after bariatric surgery than CO-participants (total body weight loss %: 5.5 % vs. 26.2 %, p = 0.0004). After a mixed meal, satiety and abdominal fullness tended to be lowest in HO-surgery and did not correlate with levels of GLP-1 or PYY. Levels of PYY (11,151 ± 1667 pmol/l/h vs. 8099 ± 1235 pmol/l/h, p = 0.028) and GLP-1 (20,975 ± 2893 pmol/l/h vs. 13,060 ± 2357 pmol/l/h, p = 0.009) were significantly higher in the HO-surgery vs. CO-surgery group. Abundance of Enterobacteriaceae and Streptococcus was increased in feces of HO and CO after bariatric surgery. Comparing HO patients with lean-controls revealed an increased activation in insula and cerebellum to viewing high-caloric foods in left insula and cerebellum in fMRI. CONCLUSIONS: Hypothalamic integrity is necessary for the effectiveness of bariatric surgery in humans. Peripheral changes after bariatric surgery are not sufficient to induce satiety and long-term weight loss in patients with hypothalamic damage.

Starving cancer into submission by activating BAT.

Activated brown adipose tissue (BAT) consumes copious amounts of circulating nutrients to fuel thermogenesis. Recently writing in Nature, Seki et al. show that this property can be leveraged to limit glucose availability for cancer cells and slow tumor growth, thereby adding cancer to the growing list of diseases that can potentially be treated by activating BAT.

Minimally invasivE versus open total GAstrectomy (MEGA): study protocol for a multicentre randomised controlled trial (DRKS00025765).

INTRODUCTION: The only curative treatment for most gastric cancer is radical gastrectomy with D2 lymphadenectomy (LAD). Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity, but its use has not yet been widely established in Western countries. Minimally invasivE versus open total GAstrectomy is the first Western multicentre randomised controlled trial (RCT) to compare postoperative morbidity following MIG vs open total gastrectomy (OG). METHODS AND ANALYSIS: This superiority multicentre RCT compares MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+LAD. Recruitment is expected to last for 2 years. Inclusion criteria comprise age between 18 and 84 years and planned total gastrectomy after initial diagnosis of gastric carcinoma. Exclusion criteria include Eastern Co-operative Oncology Group (ECOG) performance status >2, tumours requiring extended gastrectomy or less than total gastrectomy, previous abdominal surgery or extensive adhesions seriously complicating MIG, other active oncological disease, advanced stages (T4 or M1), emergency setting and pregnancy.The sample size was calculated at 80 participants per group. The primary endpoint is 30-day postoperative morbidity as measured by the Comprehensive Complications Index. Secondary endpoints include postoperative morbidity and mortality, adherence to a fast-track protocol and patient-reported quality of life (QoL) scores (QoR-15, EUROQOL EuroQol-5 Dimensions-5 Levels (EQ-5D), EORTC QLQ-C30, EORTC QLQ-STO22, activities of daily living and Body Image Scale). Oncological endpoints include rate of R0 resection, lymph node yield, disease-free survival and overall survival at 60-month follow-up. ETHICS AND DISSEMINATION: Ethical approval has been received by the independent Ethics Committee of the Medical Faculty, University of Heidelberg (S-816/2021) and will be received from each responsible ethics committee for each individual participating centre prior to recruitment. Results will be published open access. TRIAL REGISTRATION NUMBER: DRKS00025765.

Robotic-Assisted versus Laparoscopic Left Hemicolectomy-Postoperative Inflammation Status, Short-Term Outcome and Cost Effectiveness.

Robotic-assisted colon surgery may contain advantages over the laparoscopic approach, but clear evidence is sparse. This study aimed to analyze postoperative inflammation status, short-term outcome and cost-effectiveness of robotic-assisted versus laparoscopic left hemicolectomy. All consecutive patients who received minimal-invasive left hemicolectomy at the Department of Surgery I at the University Hospital of Wuerzburg in 2021 were prospectively included. Importantly, no patient selection for either procedure was carried out. The robotic-assisted versus laparoscopic approaches were compared head to head for postoperative short-term outcomes as well as cost-effectiveness. A total of 61 patients were included, with 26 patients having received a robotic-assisted approach. Baseline characteristics did not differ among the groups. Patients receiving a robotic-assisted approach had a significantly decreased length of hospital stay as well as lower rates of complications in comparison to patients who received laparoscopic surgery (n = 35). In addition, C-reactive protein as a marker of systemic stress response was significantly reduced postoperatively in patients who were operated on in a robotic-assisted manner. Consequently, robotic-assisted surgery could be performed in a cost-effective manner. Thus, robotic-assisted left hemicolectomy represents a safe and cost-effective procedure and might improve patient outcomes in comparison to laparoscopic surgery.

Nonnormative Eating Behaviors and Eating Disorders and Their Associations With Weight Loss and Quality of Life During 6 Years Following Obesity Surgery.

Importance: Individuals with severe obesity presenting for obesity surgery (OS) frequently show nonnormative eating behaviors (NEBs) and eating disorders (EDs), but the long-term course and prospective associations with weight loss and health-related quality of life (HRQOL) remain unclear. Objective: To examine the prevalence and prospective relevance of presurgical and postsurgical NEBs and EDs according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosed through clinical interview, for weight loss and HRQOL up to 6 years following OS. Design, Setting, and Participants: In the prospective, multicenter Psychosocial Registry for Obesity Surgery cohort study, patients seeking OS were recruited at 6 OS centers in Germany and assessed at baseline before surgery and at 6 months and 1 to 6 years after surgery. From a consecutive sample of 1040 volunteers with planned OS from March 1, 2012, to December 31, 2020, a total of 748 (71.92%) were included in this study. Across follow-up, 93 of the 748 patients (12.43%) dropped out. Data were analyzed from April to November 2021. Interventions: Laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. Main Outcomes and Measures: Both NEBs and EDs were identified using the Eating Disorder Examination interview. Main outcomes were the percentage of total body weight loss (%TBWL) and HRQOL (Impact of Weight on Quality of Life-Lite; range, 0-100, with 0 indicating worst and 100 indicating best). Results: In 748 patients undergoing OS (mean [SD] age, 46.26 [11.44] years; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 48.38 [8.09]; 513 [68.58%] female), the mean (SD) %TBWL was 26.70% (9.61%), and the mean (SD) HRQOL improvement was 35.41 (20.63) percentage points across follow-up. Both NEBs and EDs were common before surgery, with postsurgical improvements of varying degrees. Whereas NEBs and EDs did not reveal significant prospective associations with %TBWL, loss-of-control eating at follow-up was concurrently associated with lower %TBWL (estimate, -0.09; 95% CI, -0.14 to -0.04). Loss-of-control eating (estimate, -0.10; 95% CI, -0.17 to -0.03 percentage points) and binge-eating disorder of low frequency and/or limited duration (estimate, -6.51; 95% CI, -12.69 to -0.34 percentage points) at follow-up showed significant prospective associations with lower HRQOL. Conclusions and Relevance: This cohort study found prospective relevance of loss-of-control eating and binge-eating disorder of low frequency and/or limited duration for reduced long-term HRQOL following OS. These findings underline the importance of monitoring both NEBs, especially loss-of-control eating, and EDs in the long term postsurgically to identify patients in need of targeted prevention or psychotherapy.

Evolution of endoscopic vacuum therapy for upper gastrointestinal leakage over a 10-year period: a quality improvement study.

BACKGROUND: Endoscopic vacuum therapy (EVT) is an effective treatment option for leakage of the upper gastrointestinal (UGI) tract. The aim of this study was to evaluate the clinical impact of quality improvements in EVT management on patients' outcome. METHODS: All patients treated by EVT at our center during 2012-2021 were divided into two consecutive and equal-sized cohorts (period 1 vs. period 2). Over time several quality improvement strategies were implemented including the earlier diagnosis and EVT treatment and technical optimization of endoscopy. The primary endpoint was defined as the composite score MTL30 (mortality, transfer, length-of-stay > 30 days). Secondary endpoints included EVT efficacy, complications, in-hospital mortality, length-of-stay (LOS) and nutrition status at discharge. RESULTS: A total of 156 patients were analyzed. During the latter period the primary endpoint MTL30 decreased from 60.8 to 39.0% (P = .006). EVT efficacy increased from 80 to 91% (P = .049). Further, the need for additional procedures for leakage management decreased from 49.9 to 29.9% (P = .013) and reoperations became less frequent (38.0% vs.15.6%; P = .001). The duration of leakage therapy and LOS were shortened from 25 to 14 days (P = .003) and 38 days to 25 days (P = .006), respectively. Morbidity (as determined by the comprehensive complication index) decreased from 54.6 to 46.5 (P = .034). More patients could be discharged on oral nutrition (70.9% vs. 84.4%, P = .043). CONCLUSIONS: Our experience confirms the efficacy of EVT for the successful management of UGI leakage. Our quality improvement analysis demonstrates significant changes in EVT management resulting in accelerated recovery, fewer complications and improved functional outcome.

Endoscopic Management of Large Leakages After Upper Gastrointestinal Surgery.

Background: Endoscopic vacuum therapy (EVT) is an evidence-based option to treat anastomotic leakages of the upper gastrointestinal (GI) tract, but the technical challenges and clinical outcomes of patients with large defects remain poorly described. Methods: All patients with leakages of the upper GI tract that were treated with endoscopic negative pressure therapy at our institution from 2012-2021 were analyzed. Patients with large defects (>30 mm) as an indicator of complex treatment were compared to patients with smaller defects (control group). Results: Ninety-two patients with postoperative anastomotic or staplerline leakages were identified, of whom 20 (21.7%) had large defects. Compared to the control group, these patients required prolonged therapy (42 vs. 14 days, p < 0.001) and hospital stay (63 vs. 26 days, p < 0.001) and developed significantly more septic complications (40 vs. 17.6%, p = 0.027.) which often necessitated additional endoscopic and/or surgical/interventional treatments (45 vs. 17.4%, p = 0.007.) Nevertheless, a resolution of leakages was achieved in 80% of patients with large defects, which was similar compared to the control group (p = 0.42). Multiple leakages, especially on the opposite side, along with other local unfavorable conditions, such as foreign material mass, limited access to the defect or extensive necrosis occurred significantly more often in cases with large defects (p < 0.001). Conclusions: Overall, our study confirms that EVT for leakages even from large defects of the upper GI tract is feasible in most cases but comes with significant technical challenges.