Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial)

BACKGROUND: Emerging attempts have been made to reduce operative trauma and improve cosmetic results of laparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural transluminal endoscopic surgery (NOTES) and single-port laparoscopic cholecystectomy (SPLC). Many retrospective case series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a randomized controlled trial, patient's satisfaction on cosmesis is still controversially debated. METHODS/DESIGN: The SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study comparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC) in elective surgery. The hypothesis and primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image 12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type questionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks after surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by a visual analogue scale and the use of analgesics. Operative time, surgeon's experience with SPLC and 4PLC, use of additional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intra- and postoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned either to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th postoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05 and beta = 0.90, drop out rate of 10%) resulted in a number of 55 randomized patients per arm. DISCUSSION: The SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess cosmesis and body image after SPLC

Where Oncologic and Surgical Complication Scoring Systems Collide: Time for a New Consensus for CRS/HIPEC

INTRODUCTION Morbidity and mortality rates after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are important quality parameters to compare peritoneal surface malignancy centers. A major problem to assess postoperative outcomes among centers is the inconsistent reporting due to two coexisting systems, the diagnose-based common terminology criteria for adverse events (CTCAE) classification and the therapy-oriented Clavien-Dindo classification. We therefore assessed and compared both reporting systems. PATIENTS AND METHODS Complications after CRS/HIPEC were recorded in 147 consecutive patients and independently graded by an expert board using both systems. In a next step, a group of residents, experienced surgeons, and medical oncologists evaluated a set of twelve real complications, either with the Clavien-Dindo or CTCAE classification. RESULTS The postoperative complication rate after CRS/HIPEC was 37 % (54/147), 6.8 % (10/147) were reoperated, and three (2 %) patients died. The most frequent complications were intestinal fistula or abscess, pulmonary complications, and ileus. Grading of complications with the CTCAE classification resulted in a significantly higher major morbidity rate compared to the Clavien-Dindo classification (25 vs. 8 %, p = 0.001). Evaluating a set of complications, residents, surgeons, and oncologists correctly assessed significantly more complications with the Clavien-Dindo compared to the CTCEA classification (p < 0.001). In addition, all participants evaluated the Clavien-Dindo classification as more simple. Residents (p < 0.001) and surgeons (p < 0.01) required less time with the Clavien-Dindo classification; there was no difference for oncologist. CONCLUSION In conclusion, our data indicate that there is a different interpretation of severity grades of complications after CRS/HIPEC between the two classifications. There is a need for a common language in the field of CRS/HIPEC, which should be defined by a new consensus to compare surgical outcomes

Sleeve Gastrectomy or Gastric Bypass: a “Post-Code” Lottery? A Comprehensive National Analysis of the Utilization of Bariatric Surgery in Switzerland Between 2011–2017

Background: Sleeve gastrectomy (SG) recently became the most frequently performed bariatric surgery (BS) worldwide, overtaking the long-time standard Roux-en-Y gastric bypass (RYGB). Main indications for one or the other procedure show large inter-center variations and warrant further investigations. Objectives: The aim of this study was to identify the influencers of primary BS selection in Switzerland. Setting: Switzerland. Methods: Retrospective analysis of all hospitalizations in Switzerland January 1, 2011 through December 31, 2017 with anonymized data provided by the Swiss Federal Statistical Office. BS procedures were identified based on ICD-10 and national surgical codes. Statistical analyses were performed with R. Results: During the study period 27,375 BS were performed. The annual BS caseload doubled over time, whereas inpatient complications decreased (∼-33%). RYGB was the prevailing procedure, although its annual proportion decreased from 80% to 70% over 7 years. Meanwhile, use of SG increased from 14% to 23%. Primary RYGB and SG had similar rates of inpatient mortality (∼.05%) and morbidity (8.0 versus 7.4%, P =.148), with the exception of higher ileus rates following RYGB (.7 versus .1%, P < .001). Patient-related factors favoring the indication of SG were male sex, extremes of age, and metabolic co-morbidities , while gastroesophageal reflux disease and private insurance-favored RYGB. Strikingly, differences between geographic regions outweighed patient-related factors in procedure selection: inhabitants of German- and Italian-speaking areas had higher likelihood (OR 4.6; 3.9, P < .001) to receive SG than those in French-speaking areas. Conclusion: Geographic differences in primary BS procedure selection indicate a lack of objective rationales. Long-term risk-benefit and cost-effectiveness analyses are needed to assist evidence-based decision making

Toward a Consensus on Centralization in Surgery

OBJECTIVES To critically assess centralization policies for highly specialized surgeries in Europe and North America and propose recommendations. BACKGROUND/METHODS Most countries are increasingly forced to maintain quality medicine at a reasonable cost. An all-inclusive perspective, including health care providers, payers, society as a whole and patients, has ubiquitously failed, arguably for different reasons in environments. This special article follows 3 aims: first, analyze health care policies for centralization in different countries, second, analyze how centralization strategies affect patient outcome and other aspects such as medical education and cost, and third, propose recommendations for centralization, which could apply across continents. RESULTS Conflicting interests have led many countries to compromise for a health care system based on factors beyond best patient-oriented care. Centralization has been a common strategy, but modalities vary greatly among countries with no consensus on the minimal requirement for the number of procedures per center or per surgeon. Most national policies are either partially or not implemented. Data overwhelmingly indicate that concentration of complex care or procedures in specialized centers have positive impacts on quality of care and cost. Countries requiring lower threshold numbers for centralization, however, may cause inappropriate expansion of indications, as hospitals struggle to fulfill the criteria. Centralization requires adjustments in training and credentialing of general and specialized surgeons, and patient education. CONCLUSION/RECOMMENDATIONS There is an obvious need in most areas for effective centralization. Unrestrained, purely "market driven" approaches are deleterious to patients and society. Centralization should not be based solely on minimal number of procedures, but rather on the multidisciplinary treatment of complex diseases including well-trained specialists available around the clock. Audited prospective database with monitoring of quality of care and cost are mandatory

Online Survey on Factors Influencing Patients' Motivation to Undergo Bariatric Surgery

Given the worldwide increasing prevalence of severe obesity and considering the amount of scientific evidence demonstrating the beneficial effects of bariatric surgery (BS), it is surprising that only a fraction of patients with obesity undergo BS. We therefore conducted an anonymized online survey among individuals with a history of BS to understand factors influencing the deciding process leading to BS. Respondents were recruited on a voluntary basis from obesity-related social media groups between April and June 2020. The self-designed, non-validated questionnaire consisted of 20 questions and was open to any participants with a history of BS. Of 851 participants who started the survey, 665 completed the questionnaire (completion rate of 78.1%). Five years after BS, still 70% of the survey-participants were very satisfied or satisfied with the surgical result. However, the majority (73.3%) would have undergone BS earlier. The main motivation to choose BS was related to health status or quality of life. Important characteristics for a bariatric surgeon to obtain patients' trust are "taking time and listen" (74.7%), empathy (64%) and sympathy (56%). Post-operative satisfaction with the surgical outcome was high and long-lasting in this large cohort of BS patients. However, most participants would retrospectively have undergone BS earlier. The main reason to choose BS as treatment for their obesity were impaired physical health or reduced quality of life. Nearby location to patients' residence and availability of surgeons with empathy were decisive motives for bariatric centre selection. Keywords: bariatric surgery; characteristics of bariatric surgeons; choice for bariatric centre; decision-making for bariatric surgery; reasons for bariatric surgery; survey

Roux-en-Y gastric bypass surgery changes fungal and bacterial microbiota in morbidly obese patients—A pilot study

The Roux-en-Y gastric bypass (RYGB) remains the most effective treatment for morbidly obese patients to lower body weight and improve glycemic control. There is recent evidence that the mycobiome (fungal microbiome) can aggravate disease severity in a number of diseases including inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and hepatitis; moreover, a dysbiotic fungal microbiota has been reported in the obese. We characterized fungal and bacterial microbial composition in fecal samples of 16 morbidly obese patients before and three months after RYGB surgery and compared with nine healthy controls. We found that RYGB surgery induced a clear alteration in structure and composition of the gut fungal and bacterial microbiota. Beta diversity analysis revealed significant differences in bacterial microbiota between obese patients before surgery and healthy controls (P < 0.005) and a significant, unidirectional shift in RYGB patients after surgery (P < 0.001 vs. before surgery). In contrast, there was no significant difference in fungal microbiota between groups but individually specific changes after RYGB surgery. Interestingly, RYGB surgery induced a significant reduction in fungal alpha diversity namely Chao1, Sobs, and Shannon diversity index (P<0.05, respectively) which contrasts the trend for uniform changes in bacteria towards increased richness and diversity post-surgery. We did not observe any inter-kingdom relations in RYGB patients but in the healthy control cohort and there were several correlations between fungi and bacteria and clinical parameters (P<0.05, respectively) that warrant further research. Our study identifies changes in intestinal fungal communities in RYGB patients that are distinct to changes in the bacterial microbiota

How to establish benchmarks for surgical outcomes?: A checklist based on an international expert Delphi consensus

OBJECTIVE: To define a standardized methodology for establishing benchmarks for relevant outcomes in surgery. SUMMARY BACKGROUND DATA: Benchmarking is an established tool to improve quality in industry and economics, and is emerging in assessing outcome values in surgery. Despite a recent 10-step approach to identify such benchmark values, a standardized and more widely agreed-on approach is still lacking. METHODS: A multinational web-based Delphi survey with a focus on methodological requirements for establishing benchmarks for surgical outcomes was performed. Participants were selected among internationally renowned specialists in abdominal, vascular, and thoracic surgery. Consensus was defined as ≥70% agreement and results were used to develop a checklist to establish benchmarks in surgery. RESULTS: Forty-one surgical opinion leaders from 19 countries and 5 continents were involved. Experts' response rates were 98% and 80% in rounds 1 and 2, respectively. Upon completion of the final Delphi round, consensus was successfully achieved for 26 of 36 items covering the following areas: center eligibility, validation of databases, patient cohort selection, procedure selection, duration of follow-up, statistical analysis, and publication requirements regarding center-specific outcomes. CONCLUSIONS: This multinational Delphi survey represents the first expert-led process for developing a standardized approach for establishing benchmarks for relevant outcome measures in surgery. The provided consensual checklist customizes the methodology of outcome reporting in surgery and thus improves reproducibility and comparability of data and should ultimately serve to improve quality of care

Effects of art on surgical patients: a systematic review and meta-analysis

OBJECTIVES: The aim of the study was to assess the effect of art including ambient features such as music, interior design including visual art, and architectural features on health outcomes in surgical patients. BACKGROUND: Healing environments can have a positive influence on many patients, but data focusing on art in surgical patients remain scarce. METHODS: We conducted a systematic search following the PRISMA guidelines from January 2000 to October 2014 on art in surgical patients. For music interventions, we pooled controlled studies measuring health outcomes (eg, pain, anxiety, blood pressure, and heart rate) in a meta-analysis. For other art forms (ambient and architectural features and interior design), we did a narrative review, also including nonsurgical patients, and looked for examples covering 3 countries. RESULTS: Our search identified 1101 hits with 48 studies focusing on art in surgical patients: 47 studies on musical intervention and 1 on sunlight. The meta-analysis of these studies disclosed significant effects for music on pain after surgery, anxiety, systolic blood pressure, and heart rate, when compared with control groups without music. Effects of music were larger with self-selected music, and lower in surgical interventions performed under general anesthesia. Interior design features such as nature images and more spacious rooms, and architectural features providing more sunlight had positive effects on anxiety and postoperative pain. CONCLUSIONS: Self-selected music for surgical patients is an effective and low-cost intervention to enhance well being and possibly faster recovery. Although potentially very important, the impact of environmental features and spacious architecture with wide access to sunlight remains poorly explored in surgery. Further experimental research is needed to better assess the magnitude of the impact and cost effectiveness