Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass: A Randomized Clinical Trial.

Importance: Laparoscopic sleeve gastrectomy (SG) and laparoscopic Roux-en-Y gastric bypass (RYGB) are widely used bariatric procedures for which comparative efficacy and safety remain unclear. Objective: To compare perioperative outcomes in SG and RYGB. Design, Setting, and Participants: In this registry-based, multicenter randomized clinical trial (Bypass Equipoise Sleeve Trial), baseline and perioperative data for patients undergoing bariatric surgery from October 6, 2015, to March 31, 2022, were analyzed. Patients were from university, regional, county, and private hospitals in Sweden (n = 20) and Norway (n = 3). Adults (aged ≥18 years) eligible for bariatric surgery with body mass indexes (BMIs; calculated as weight in kilograms divided by height in meters squared) of 35 to 50 were studied. Interventions: Laparoscopic SG or RYGB. Main Outcomes and Measures: Perioperative complications were analyzed as all adverse events and serious adverse events (Clavien-Dindo grade >IIIb). Ninety-day mortality was also assessed. Results: A total of 1735 of 14 182 eligible patients (12%; 1282 [73.9%] female; mean (SD) age, 42.9 [11.1] years; mean [SD] BMI, 40.8 [3.7]) were included in the study. Patients were randomized and underwent SG (n = 878) or RYGB (n = 857). The mean (SD) operating time was shorter in those undergoing SG vs RYGB (47 [18] vs 68 [25] minutes; P < .001). The median (IQR) postoperative hospital stay was 1 (1-1) day in both groups. The 30-day readmission rate was 3.1% after SG and 4.0% after RYGB (P = .33). There was no 90-day mortality. The 30-day incidence of any adverse event was 40 (4.6%) and 54 (6.3%) in the SG and RYGB groups, respectively (odds ratio, 0.71; 95% CI, 0.47-1.08; P = .11). Corresponding figures for serious adverse events were 15 (1.7%) for the SG group and 23 (2.7%) for the RYGB group (odds ratio, 0.63; 95% CI, 0.33-1.22; P = .19). Conclusions and Relevance: This randomized clinical trial of 1735 patients undergoing primary bariatric surgery found that both SG and RYGB were performed with a low perioperative risk without clinically significant differences between groups. Trial Registration: ClinicalTrials.gov Identifier: NCT02767505.

Glycemic variability and hypoglycemia before and after Roux-en-Y Gastric Bypass and Sleeve Gastrectomy - A cohort study of females without diabetes.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) lead to lower fasting glucose concentrations, but might cause higher glycemic variability (GV) and increased risk of hypoglycemia. However, it has been sparsely studied in patients without preoperative diabetes under normal living conditions. OBJECTIVES: To study 24-hour interstitial glucose (IG) concentrations, GV, the occurrence of hypoglycemia and dietary intake before and after laparoscopic RYGB and SG in females without diabetes. SETTING: Outpatient bariatric units at a community and a university hospital. METHODS: Continuous glucose monitoring and open-ended food recording over 4 days in 4 study periods: at baseline, during the preoperative low-energy diet (LED) regimen, and at 6 and 12 months postoperatively. RESULTS: Of 47 patients included at baseline, 83%, 81%, and 79% completed the remaining 3 study periods. The mean 24-hour IG concentration was similar during the preoperative LED regimen and after surgery and significantly lower compared to baseline in both surgical groups. GV was significantly increased 6 and 12 months after surgery compared to baseline. The self-reported carbohydrate intake was positively associated with GV after surgery. IG concentrations below 3.9 mmol/L were observed in 14/25 (56%) of RYGB- and 9/12 (75%) of SG-treated patients 12 months after surgery. About 70% of patients with low IG concentrations also reported hypoglycemic symptoms. CONCLUSIONS: The lower IG concentration in combination with the higher GV after surgery, might create a lower margin to hypoglycemia. This could help explain the increased occurrence of hypoglycemic episodes after RYGB and SG.

Laparoscopic ventral hernia repair: early follow-up of a randomized controlled study of primary fascial closure before mesh placement.

BACKGROUND: Suturing of the hernia aperture in laparoscopic ventral hernia repair has increased during the past decade. The primary aim of this is to restore the anatomy of the abdominal wall. Closure of the aperture, however, may cause additional tension in the abdominal wall which could increase postoperative pain. The aim of this study was to investigate whether suturing of the hernia aperture affects postoperative pain and hernia-site complications, including seroma, infection, pseudohernia, and mesh migration, 3 months after repair. METHODS: Some 192 patients with a midline hernia between 2 and 8 cm in transverse diameter were included in a randomized controlled double-blinded multicentre study. Patients were randomized to mesh repair with (intervention) or without (control) suturing of the hernia aperture before mesh placement. Patients completed the Ventral Hernia Pain Questionnaire before and 3 months after surgery. Abdominal wall pain and hernia-site complications were assessed 3 months after surgery. RESULTS: Ninety-seven patients were randomized to the intervention group and 95 to the control group. Among all patients, median age and BMI was 56 years and 31 kg/m2 respectively. Overall pain experienced decreased by 3 months after operation (P < 0.001). There was no difference between groups regarding hernia-site complications or pain experienced during the past week (13 versus 23 patients; P = 0.111). Seroma and pseudohernia occurred in 13 and 11 patients in the intervention and control groups respectively (P = 0.975 and P = 0.977). CONCLUSION: Restoration of the abdominal wall anatomy by suturing the hernia aperture before mesh placement does not increase the risk of hernia-site complication or pain 3 months after surgery. This implies that fascial suturing of the aperture can be justified if there are potential long-term benefits such as lower recurrence and/or complication rates. Registration number: ISRCTN51495042 (http://www.controlled-trials.com).

Differences in Cholecystectomy Outcomes and Operating Time Between Male and Female Surgeons in Sweden.

Importance: Female surgeons are still in the minority worldwide, and highlighting gender differences in surgery is important in understanding and reducing inequities within the surgical specialty. Studies on different surgical procedures indicate equal results, or safer outcomes, for female surgeons, but it is still unclear whether surgical outcomes of gallstone surgery differ between female and male surgeons. Objective: To examine the association of the surgeon's gender with surgical outcomes and operating time in elective and acute care cholecystectomies. Design, Setting, and Participants: A population-based cohort study based on data from the Swedish Registry of Gallstone Surgery was performed from January 1, 2006, to December 31, 2019. The sample included all registered patients undergoing cholecystectomy in Sweden during the study period. The follow-up time was 30 days. Data analysis was performed from September 1 to September 7, 2022, and updated March 24, 2023. Exposure: The surgeon's gender. Main Outcome(s) and Measure(s): The association between the surgeon's gender and surgical outcomes for elective and acute care cholecystectomies was calculated with generalized estimating equations. Differences in operating time were calculated with mixed linear model analysis. Results: A total of 150 509 patients, with 97 755 (64.9%) undergoing elective cholecystectomies and 52 754 (35.1%) undergoing acute care cholecystectomies, were operated on by 2553 surgeons, including 849 (33.3%) female surgeons and 1704 (67.7%) male surgeons. Female surgeons performed fewer cholecystectomies per year and were somewhat better represented at universities and private clinics. Patients operated on by male surgeons had more surgical complications (odds ratio [OR], 1.29; 95% CI, 1.19-1.40) and total complications (OR, 1.12; 95% CI, 1.06-1.19). Male surgeons had more bile duct injuries in elective surgery (OR, 1.69; 95% CI, 1.22-2.34), but no significant difference was apparent in acute care operations. Female surgeons had significantly longer operation times. Male surgeons converted to open surgery more often than female surgeons in acute care surgery (OR, 1.22; 95% CI, 1.04-1.43), and their patients had longer hospital stays (OR, 1.21; 95% CI, 1.11-1.31). No significant difference in 30-day mortality could be demonstrated. Conclusions and Relevance: The results of this cohort study indicate that female surgeons have more favorable outcomes and operate more slowly than male surgeons in elective and acute care cholecystectomies. These findings may contribute to an increased understanding of gender differences within this surgical specialty.

Relationship between surgical volume and outcomes in elective and acute cholecystectomy: nationwide, observational study.

BACKGROUND: High surgical volumes are attributed to improved quality of care, especially for extensive procedures. However, it remains unknown whether high-volume surgeons and hospitals have better results in gallstone surgery. The aim of this study was to investigate whether operative volume affects outcomes in cholecystectomies. METHODS: A registry-based cohort study was performed, based on the Swedish Registry of Gallstone Surgery. Cholecystectomies from 2006 to 2019 were included. Annual volumes for the surgeon and hospital were retrieved. All procedures were categorized into volume-based quartiles, with the highest group as reference. Low volume was defined as fewer than 20 operations per surgeon per year and fewer than 211 cholecystectomies per hospital per year. Differences in outcomes were analysed separately for elective and acute procedures. RESULTS: The analysis included 154 934 cholecystectomies. Of these, 101 221 (65.3 per cent) were elective and 53 713 (34.7 per cent) were acute procedures. Surgeons with low volumes had longer operating times (P < 0.001) and higher conversion rates in elective (OR 1.35; P = 0.023) and acute (OR 2.41; P < 0.001) operations. Low-volume surgeons also caused more bile duct injuries (OR 1.41; P = 0.033) and surgical complications (OR 1.15; P = 0.033) in elective surgery, but the results were not statistically significant for acute procedures. Low-volume hospitals had more bile duct injuries in both elective (OR 1.75; P = 0.002) and acute (OR 1.96; P = 0.003) operations, and a higher mortality rate after acute surgery (OR 2.53; P = 0.007). CONCLUSION: This study has demonstrated that operative volumes influence outcomes in cholecystectomy. The results indicate that gallstone surgery should be performed by procedure-dedicated surgeons at hospitals with high volumes of this type of benign surgery.

Surgeons who perform an operation are often thought to have better results. It remains unknown whether this is true for gallstone surgery. This research study investigated whether the surgeon's and hospital's volume of operations affects results after gallstone operations. The study was based on the Swedish Registry of Gallstone Surgery, in which all gallstone operations in Sweden are registered. Some 14 000 operations are performed every year. Operations from 2006 to 2019 were included. The annual volume for each surgeon was counted and all operations were divided into four groups. The operating time and number of unwanted events were compared between the groups, for both planned and acute operations. : The study included 154 934 operations. Of these, 101 221 (65.3 per cent) were planned and 53 713 (34.7 per cent) were acute. Surgeons with low volumes had longer operating times and higher risk of a change in technique from keyhole to open surgery, in both planned and acute operations. Surgeons and hospitals with low volumes also had more unwanted events after planned operations. The risk of death at a hospital with low volumes was slightly higher in acute surgery. This study has shown that the surgeon's and hospital's volumes affect results after gallstone surgery, suggesting that this type of surgery should be performed by surgeons and at hospitals that perform these operations frequently.

Female Groin Hernia Repairs in the Swedish Hernia Register 1992-2022: A Review With Updates.

Introduction: Groin hernias in women is much less common than in men; it constitutes only 9% of all groin hernia operations. Historically, studies have been performed on men and the results applied to both genders. However, prospectively registered operations within national registers have contributed to new knowledge regarding groin hernias in women. The aim of this paper was to investigate and present a body of literature based upon the Swedish Hernia Register together with recent data from the register's annual report. Patients and Methods: PubMed and Embase were searched for studies based on the Swedish Hernia Register between 1992 and 2023. Based on the initial reading of abstracts, studies that presented results separately for women were selected and read. Recent data were acquired from the 2022 annual report of the Swedish Hernia Register. Results: A total of 73 studies of interest were identified. Of these, 52 included women, but only 19 presented separate results for women. Four themes emerged and were analysed further: emergency surgery and mortality, femoral hernias, the risk of reoperation for recurrence, and chronic pain following female groin hernia repairs. Discussion: Studies from the Swedish Hernia Register clearly describe that both the presentation of hernias and outcomes after repair differ significantly between the two genders. The differences that have been identified over the years have been incorporated into the national guidelines. Register data indicates that the guidelines have been implemented and are fairly well adhered to. As a result, significant improvements in outcomes regarding recurrences have been made for women with groin hernias in Sweden.

The Impact of Hospital Level of Care on the Management of Acute Cholecystitis: a Population-Based Study.

BACKGROUND: The organization of healthcare could have an impact on the outcome of patients treated for acute cholecystitis (AC). The aim of this study was to analyze the way in which patients with AC are managed relative to the level of care by the treating hospital. METHODS: Data were collected from the Swedish Register for Gallstone Surgery and ERCP (GallRiks). Cholecystectomies between 2010 and 2019 were included. The inclusion criterion was acute cholecystectomy in patients with AC operated at either tertiary referral centers (TRCs) or regional hospitals. RESULTS: A total of 24,194 cholecystectomies with AC met the inclusion criterion. The time between admission and acute surgery was significantly elongated at TRCs compared with regional hospitals (2.2 ± 1.7 days vs. 1.6 ± 1.4 days, mean ± SD; p < 0.0001). Patients with a history of AC were more frequent at TRC (10.1% vs. 8.9%, p < 0.0056) and had a higher adverse event rate compared with those at regional hospitals (OR 1.61; CI 1.40-1.84, p < 0.0001). Surprisingly, an increased number of hospital beds correlated slightly with an increased number of days between admission and surgery (R2 = 0.132; p = 0.0075). CONCLUSION: Compared with regional hospitals, patients with AC had to wait longer at TRCs before surgery. A history of AC significantly increased the risk of adverse events. These findings indicate that logistic and organizational aspects of hospital care may affect the management of patients with AC. However, whether these findings can be generalized to healthcare organizations outside Sweden requires further investigation.

[Swedish gallstone surgery during the covid-19 pandemic]. / Fler akuta gallstensoperationer och färre elektiva under pandemin.

The covid-19 pandemic has necessitated reallocation of health care resources. This has raised concerns about the risks associated with postponing surgery for benign conditions that are given low priority. Data from the population-based Swedish National Register for Gallstone Surgery (GallRiks) show that the total number of procedures carried out during the initial months of each wave of the pandemic decreased. This was followed by a moderate increase in the number of procedures performed for acute cholecystitis, biliary pancreatitis, and obstructive jaundice. The consequences of the delayed surgery in the community at large and how this has affected health-related quality of life for patients having their procedure postponed remain to be evaluated, but so far it does not seem to have caused a major impact on public health.

Learning by doing: an observational study of the learning curve for ultrasonic fundus-first dissection in elective cholecystectomy.

BACKGROUND: Surgical safety and patient-related outcomes are important considerations when introducing new surgical techniques. Studies about the learning curves for different surgical procedures are sparse. The aim of this observational study was to evaluate the learning curve for ultrasonic fundus-first (FF) dissection in elective laparoscopic cholecystectomy (LC). METHODS: The study was conducted at eight hospitals in Sweden between 2017 and 2019. The primary endpoint was dissection time, with secondary endpoints being intra- and postoperative complication rates and the surgeon's self-assessed performance level. Participating surgeons (n = 16) were residents or specialists who performed LC individually but who had no previous experience in ultrasonic FF dissection. Each surgeon performed fifteen procedures. Video recordings from five of the procedures were analysed by two external surgeons. Patient characteristics and data on complications were retrieved from the Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks). RESULTS: Dissection time decreased as experience increased (p = 0.001). Surgeons with limited experience showed more rapid progress. The overall complication rate was 14 (5.8%), including 3 (1.3%) potentially technique-related complications. Video assessment scores showed no correlation with the number of procedures performed. The self-assessed performance level was rated lower when the operation was more complicated (p < 0.001). CONCLUSIONS: Our results show that dissection time decreased with increasing experience. Most surgeons identified both favourable and unfavourable aspects of the ultrasonic FF technique. The ultrasonic device is considered well suited for gallbladder surgery, but most participating surgeons preferred to dissect the gallbladder the traditional way, beginning in the triangle of Calot. Nevertheless, LC with ultrasonic FF dissection can be considered easy to learn with a low complication rate during the initial learning curve, for both residents and specialists.

Impact of the COVID-19 pandemic on the management of gallstone surgery: A Swedish population-based study.

BACKGROUND: The SARS-CoV-2 pandemic has had a significant impact on healthcare delivery. As resources are reallocated, surgery for benign conditions such as gallstone disease is often given low priority. We do not know how this has affected the risk of patients with uncomplicated gallstone disease to develop acute cholecystitis, biliary pancreatitis, or obstructive jaundice. METHODS: The study was based on the population-based Swedish Register of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography. The period prior to the first cases of COVID-19 in Sweden, that is, April 2015-March 2020, was compared to the period April 2020-March 2021 during the pandemic. Stratification was made for factors potentially related to priority decisions. RESULTS: Altogether, 78,211 procedures were performed during the period of the study. The ratio of procedures performed during April 2020-March 2021 in the previous 5 years was 0.960 (p = 0.113). The ratio of procedures on patients aged <65 years was 0.945 (p = 0.008), on patients aged 65-80 years was 0.964 (p = 0.423), on patients aged >80 years was 1.336 (p = 0.025), on men was 1.001 (p = 0.841), on women was 0.934 (p = 0.006), on procedures completed laparoscopically was 0.964 (p = 0.190), on procedures completed with open approach was 0.659 (p = 0.044), on acute procedures was 1.218 (p = 0.016), on planned procedures was 0.791 (p < 0.001), on procedures performed for biliary colic was 0.808 (p < 0.001), on procedures performed for acute cholecystitis was 1.274 (p = 0.012), for biliary pancreatitis was 1.192 (p = 0.037), and for obstructive jaundice was 1.366 (p = 0.008). CONCLUSIONS: The COVID-19 has had a great impact on how gallstone surgery has been organized over the last 2 years. The decreased number of planned procedures probably reflects the reallocation of resources during the pandemic. However, whether the increasing number of acute procedures is the result of postponed planned surgery or a continuation of a long-term trend toward more acute surgery remains unanswered. Further studies are needed to assess and evaluate how this has affected public health and health economics.

Outcome of ERCP related to case-volume.

BACKGROUND AND AIMS: In some studies, high endoscopic retrograde cholangiopancreatography (ERCP) case-volume has been shown to correlate to high success rate in terms of successful cannulation and fewer adverse events. The aim of this study was to analyze the association between ERCP success and complications, and endoscopist and centre case-volumes. METHODS: Data were obtained from the Swedish National Register for Gallstone Surgery and ERCP (GallRiks) on all ERCPs performed for Common Bile Duct Stone (CBDS) (n = 17,873) and suspected or confirmed malignancy (n = 6152) between 2009 and 2018. Successful cannulation rate, procedure time, intra- and postoperative complication rates and post-ERCP pancreatitis (PEP) rate, were compared with endoscopist and centre ERCP case-volumes during the year preceding the procedure as predictor. RESULTS: In multivariable analyses of the CBDS group adjusting for age, gender and year, a high endoscopist case-volume was associated with higher successful cannulation rate, lower complication and PEP rates, and shorter procedure time (p < 0.05). Centres with a high annual case-volume were associated with high successful cannulation rate and shorter procedure time (p < 0.05), but not lower complication and PEP rates. When indication for ERCP was malignancy, a high endoscopist case-volume was associated with high successful cannulation rate and low PEP rates (p < 0.05), but not shorter procedure time or low complication rate. Centres with high case-volume were associated with high successful cannulation rate and low complication and PEP rates (p < 0.05), but not shorter procedure time. CONCLUSIONS: The results suggest that higher endoscopist and centre case-volumes are associated with safer ERCP and successful outcome.

Regional variations in Sweden over time regarding the surgical treatment of acute cholecystitis: a population-based register study.

OBJECTIVE: To provide optimal health care for patients with acute cholecystitis in need of acute cholecystectomy, resource allocation has to be optimized. The aim of this study was to assess possible regional inequity regarding the treatment of acute cholecystitis and explore regional differences in the management of acute cholecystitis. METHODS: Data were retrieved from the Swedish National Register for Gallstone Surgery and Endoscopic Retrograde CholangioPancreatography. Between January 2010 and December 2019, 22,985 patients who underwent cholecystectomy for acute cholecystitis and without prior history of acute cholecystitis were included in the study. The ratio of cholecystectomies with acute cholecystitis performed within two days of admission to hospital compared to population density was studied. Furthermore, the proportion of acute performed cholecystectomies within two days of admission in regions, with or without tertiary care centers, was also examined. RESULTS: No correlation between population density and proportion of acute performed cholecystectomies was found. Regions without tertiary care centers had a higher proportion of acute cholecystectomies performed within two days (5-10%). The difference in the ratio of acute cholecystectomies within two days of admission was significant for all years investigated except 2010. CONCLUSIONS: The presence of a tertiary referral center within the region had a greater influence than the population density on the chance of undergoing acute cholecystectomy for patients with acute cholecystitis. There are several potential explanations for this, one being an interference of the needs of patients requiring tertiary referral center care with the needs of patients in need of acute care surgery.

Lower Interstitial Glucose Concentrations but Higher Glucose Variability during Low-Energy Diet Compared to Regular Diet-An Observational Study in Females with Obesity.

This is an observational study of interstitial glucose (IG) concentrations, IG variability and dietary intake under free-living conditions in 46 females with obesity but without diabetes. We used continuous glucose monitoring, open-ended food recording and step monitoring during regular dietary intake followed by a low-energy diet (LED). Thirty-nine participants completed both study periods. The mean BMI at baseline was 43.6 ± 6.2 kg/m2. Three weeks of LED resulted in a mean weight loss of 5.2% with a significant reduction in diurnal IG concentration but with greater glycemic variability observed during LED. The mean 24 h IG concentration decreased from 5.8 ± 0.5 mmol/L during the regular diet period to 5.4 ± 0.5 mmol/L (p < 0.001) during LED, while the mean amplitude of glycemic excursion increased from 1.5 ± 0.7 to 1.7 ± 0.7 mmol/L (p = 0.031). The positive incremental area under the curve at breakfast was significantly larger for LED compared to regular diet. The daily fiber intake and the glycemic index of breakfast meals were significantly associated with the glycemic variability during regular dietary intake. In conclusion, the 24 h mean IG concentration was lower but with more pronounced glycemic variability during LED compared to a regular diet.

Incisional hernias following gallstone surgery. A population-based study.

BACKGROUND: The aim of this study was to determine the incidence of incisional hernia (IH) in a population-based cohort following gallstone surgery and to identify associated risk factors. METHODS: All cholecystectomies registered in the Swedish register for cholecystectomy and ERCP from 2006 to 2014 were identified. Data regarding post-procedural development of IH was obtained from the National Patient Register. RESULTS: A total of 81 964 cholecystectomies were identified. A laparoscopic, open, and minilaparotomy technique was used in 70 031, 10 379 and 1554 procedures, respectively. The five-year cumulative incidence of IH was 1.04 per cent in the laparoscopic group, 3.37 per cent in the open group, and 2.11 per cent in the minilaparotomy group. Obesity (hazard ratio (HR) 4.11, 95 per cent confidence interval [CI] 3.37 to 5.01), open surgical technique (HR 2.97, CI 2.57 to 3.42), liver cirrhosis (HR 2.95, CI 1.58 to 5.51), chronic kidney disease (HR 1.95, CI 1.19 to 3.21), minilaparotomy (HR 1.79, CI 1.23 to 2.60), age > median (HR 1.43, CI 1.25 to 1.65), and chronic pulmonary disease (HR 1.28, CI 1.05 to 1.57) were found to significantly predict the development of IH. CONCLUSION: Laparoscopic cholecystectomy comes with a lower risk of IH compared to open techniques.

BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy.

BACKGROUND: Laparoscopic gastric bypass (LGBP) is a well-documented surgical intervention for severe obesity. Recently, laparoscopic sleeve gastrectomy (LSG) has gained increased popularity. Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods. METHOD: BEST is a randomized, registry-based, multicenter trial comparing LGBP and LSG. The trial has two primary outcomes; rates of substantial complications (SC) and total body weight loss. We hypothesize that patients treated with LSG will experience 35% fewer substantial complications during the 5-year follow-up compared to patients treated with LGBP, and that the efficacy of LSG will remain within a non-inferiority margin of 5% in terms of weight loss. Our sample size calculation, using data from the Scandinavian Obesity Surgery Registry (SOReg), shows a power of 80% for SC and > 95% for weight loss at p < .025 with a total of 2100 included patients. The design of the trial will also enable comparisons within several relevant patient subgroups. CONCLUSIONS: As a large-sized, pragmatic, randomized trial, BEST will provide robust data comparing LGBP with LSG by generating long-term results on weight loss and SC's, as well as secondary outcomes and comparisons within patient subgroups. The use of a well-established registry for registration of all data facilitates a large multicenter trial, and combines the strengths of registry studies with those of a randomized trial. Clinical Trials registry: NCT02767505.

Incisional hernias following open gynecological surgery: a population-based study.

INTRODUCTION: Incisional hernia is a common and costly complication following abdominal surgery. The incidence of incisional hernia after gynecological surgery is not as well studied as that after general surgery. MATERIALS AND METHODS: The Swedish National Quality Register for Gynecological Surgery (GynOp) collects preoperative, intraoperative, and postoperative information regarding gynecological surgery. Data were extracted from 2006 to 2014. The National Patient Register (NPR) contains physicians' data from both public and private hospitals. Univariate and multivariate Cox proportional hazard analyzes were performed on risk factors. RESULTS: Between 2006 and 2014, 39,312 women undergoing open surgery were registered in GynOp. The NPR recorded 526 patients who were diagnosed with or had undergone surgery for incisional hernia. The mean follow-up was 2.8 years. Five years after surgery the cumulative incidence of incisional hernias was 2.0% (95% confidence interval 1.8-2.2%). In multivariate Cox proportional hazard analysis obesity (BMI > 30), age > 60 years, midline incision, smoking, kidney, liver, and pulmonary disease were found to predict an increased risk for incisional hernias (all p < 0.05). CONCLUSIONS: There is much to be gained if the patient can cease smoking and lose weight before undergoing abdominal surgery. The Pfannenstiel incision results in fewer incisional hernias and should be considered whenever possible.

The Impact of Groin Surgery during Childhood on the Incidence of Inguinal Hernia Repair and Its Postoperative Complications in Adult Life.

BACKGROUND: Pediatric inguinal hernia, hydrocele, and cryptorchidism are common congenital anomalies affecting children, and require surgical intervention in some cases. The association between surgical treatment of these conditions and acquired inguinal hernia later in life is poorly understood. The aim of this cohort study was to examine the effect of groin surgery during childhood on the incidence and surgical outcome of inguinal hernia repair in adult life. MATERIALS AND METHODS: Data from the Swedish Inpatient Register and the Swedish Hernia Register were cross-linked using the patient personal identity numbers. The incidence of inguinal hernia repair in patients 15 years or older in the study cohort, as well as postoperative complication rates, were compared with the expected incidence and complication rates extrapolated from the general Swedish population in 2014, stratifying for age and gender. RESULTS: Note that 68,238 children aged 0 to 14 years were found to have undergone groin surgery between 1964 and 1998. The median follow-up time after an operation in the groin was 30.8 years (21.0-50.0). Of those, 1,118 were found to have undergone inguinal hernia repair as adults (> 15 years old) between 1992 and 2013. The incidence of inguinal hernia repair in the cohort was significantly higher than that expected (1.43 [1.33-1.53]), both for men (1.32 [1.25-1.41]) and women (4.30 [3.28-5.55]). The incidence was also increased in the subgroup of patients that had undergone more than one procedure during childhood. No significant impact on postoperative complication rate, reoperation rate, or operation time was identified. CONCLUSION: Individuals undergoing surgery in the groin during childhood are at increased risk for acquired inguinal hernia surgery later in life. Inguinal surgery during childhood did not affect the outcome of hernia repair in adult age.

Can 3D Vision Improve Laparoscopic Performance in Box Simulation Training when Compared to Conventional 2D Vision?

INTRODUCTION: Three-dimensional (3D) imaging systems have been introduced in laparoscopic surgery to facilitate binocular vision and dexterity to improve surgical performance and safety. Several studies have shown the benefits of 3D imaging in laparoscopy, but until now only a few studies have assessed the outcome by using objective variables. Box trainers are affordable alternatives to virtual laparoscopic surgical training, and the possibility of using real surgical instruments makes them more realistic to use. However, the data and feedback by a virtual simulator have not, until now, been able to assess. Simball Box®, equipped with G-coder sensors®, registers the instrument movements during training and gives the same feedback like a virtual simulator. AIM: The aim of this study was to objectively evaluate the laparoscopic performance in 3D compared to conventional 2D vision by using a box simulation trainer. MATERIALS AND METHODS: Thirty surgeons, residents and consultants, participated in the study. Eighteen had no, or minimal, laparoscopic experience (novices) whereas 12 were experts. They all performed three standard box training exercises (rope race, precision cutting, and basic suturing) in Simball Box. The participants were randomized and started with either 3D HD or traditional 2D HD cameras. The exercises were instructed and supervised. All instrument movements were registered. Variations in time, linear distance, average speed, and motion smoothness were analyzed. RESULTS: The parameters time, distance, speed, and motion smoothness were significantly better when the 3D camera was used. CONCLUSION: All individuals of both subgroups achieved significantly higher speed and better motion smoothness when using 3D.

Inversed relationship between completeness of follow-up and coverage of postoperative complications in gallstone surgery and ERCP: a potential source of bias in patient registers.

OBJECTIVE: To analyse the completeness in GallRiks of the follow-up frequency in relation to the intraoperative and postoperative outcome. DESIGN: Population-based register study. SETTING: Data from the national Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (ERCP), GallRiks. POPULATION: All cholecystectomies and ERCPs recorded in GallRiks between 1 January 2006 and 31 December 2014. MAIN OUTCOME MEASURES: Outcomes for intraprocedural as well as postprocedural adverse events between units with either a 30-day follow-up of ≥90% compared with those with a less frequent follow-up (<90%). RESULTS: Between 2006 and 2014, 162 212 cholecystectomies and ERCP procedures were registered in GallRiks. After the exclusion of non-index procedures and those with incomplete data 152 827 procedures remained for final analyses. In patients having a cholecystectomy, there were no differences regarding the adverse event rates, irrespective of the follow-up frequency. However, in the more complicated endoscopic ERCP procedures, the postoperative adverse event rates were significantly higher in those with a more frequent and complete 30-day follow-up (OR 1.92; 95% CI 1.76 to 2.11). CONCLUSIONS: Differences in the follow-up frequency in registries affect the reported outcomes as exemplified by the complicated endoscopic ERCP procedures. A high and complete follow-up rate shall serve as an additional quality indicator for surgical registries.