Long-term Outcome of the Dutch Common Channel Trial (DUCATI): Preservation of Superior Weight Loss Results Without Significant Malnutrition Side Effects.

PURPOSE: The optimal bowel limb lengths for laparoscopic Roux-en-Y gastric bypass (LRYGB) to maximize weight loss while minimizing nutritional deficiencies in severe obesity treatment remain a topic of debate. The multi-center Dutch Common Channel Trial (DUCATI) aims to compare the outcomes of a very long Roux Limb Roux-en-Y gastric bypass (VLRL-LRYGB) with a standard Roux-en-Y gastric bypass (S-LRYGB). METHODS: A total of 444 patients were randomly assigned in a 1:1, double-blind manner to undergo either VLRL-RYGB or S-LRYGB. Five-year follow-up data were assessed, concentrating on weight loss, obesity-related medical conditions, complications, re-operations, and malnutrition. RESULTS: Both groups had comparable total alimentary lengths (RL + CC). The VLRL-LRYGB group demonstrated significantly greater %TWL (32.2% vs. 28.6%, p = 0.002) and %EWL (81.2% vs. 70.3%, p = 0.002) at 5 years. Eight (3.6%) patients in the VLRL-LRYGB group versus 2 (0.9%) in the S-LRYGB group (p = 0.055) needed modification surgery for malabsorption. Suboptimal clinical response rate was significantly higher (22.0% vs. 8.3%) in S-LRYGB group. No significant differences for nutrient deficiencies in favor of the S-LRYGB group were found. CONCLUSION: A 100-cm common channel with a relatively long Roux limb provides superior, sustainable weight loss over 5 years, without significantly increased rate of malabsorption-related re-operations. These results suggest that a longer Roux limb can still ensure adequate micronutrient uptake in the total alimentary tract. These findings should be considered in discussions regarding the optimal Roux-en-Y limb length for severe obesity treatment.

Concomitant Cholecystectomy for Asymptomatic Gallstones in Bariatric Surgery-Safety Profile and Feasibility in a Large Tertiary Referral Bariatric Center.

BACKGROUND: Obesity is a risk factor for gallstone formation, which can be exacerbated by bariatric surgery-induced rapid weight loss. Current guidelines do not recommend concomitant cholecystectomy (CC) for asymptomatic gallstones during the bariatric surgery procedure. However, long-term follow-up studies have shown that the incidence of post-bariatric surgery symptomatic gallstones necessitating therapeutic cholecystectomy increases to 40%. Therefore, some surgeons advocate simultaneous cholecystectomy during the bariatric surgery for asymptomatic individuals. This study aims to evaluate the safety of performing cholecystectomy for asymptomatic gallstones during the bariatric procedure. METHODS: Data from a consecutive series of patients that underwent primary laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB) or conversion of LSG to a LRYGB with or without concomitant cholecystectomy for asymptomatic gallstones between Jan 2010 and Dec 2017 were retrieved from the database. The primary endpoint was the complication rate. Secondary endpoints were the surgical operating room time (ORT) and the length of hospital stay (LOS). RESULTS: Out of the 2828 patients who were included, 120 patients underwent a concomitant cholecystectomy during their bariatric procedure (LSG or LRYGB) for asymptomatic gallbladder stones and were compared to the 2708 remaining patients who only had bariatric surgery. None of the concomitant cholecystectomy patients developed a gallbladder-related complication. There was no significant increase in the rate of minor or major complications between the CC groups and the non-CC groups (LSG: 6.7% vs. 3.2%, p=0.132; LRYGB: 0% vs. 2.3%, p =0.55; and conversion of LSG to LRYGB: 20% vs. 7.1%, p = 0.125, respectively). In addition, there was no significant increase in the length of hospital stay (1.85 ±4.19 days vs. 2.24 ±1.82, p=0.404) for LSG group and (1.75 ±2.0 vs. 2.3 ±2.1, p=0.179) for LRYGB group. Adding the cholecystectomy to the bariatric procedure only added an average of 23 min (min) (27 min when added to LSG and 18 min when added to LRYGB). CONCLUSION: As one of the largest series reviewing concomitant cholecystectomy in bariatric surgery, this study showed that in skilled laparoscopic bariatric surgical hands, concomitant cholecystectomy during bariatric surgery is safe and prevents potential future gallstone-related complications. Long-term large prospective randomized trials are needed to further clarify the recommendation of prophylactic concomitant cholecystectomy during bariatric surgery.

Midterm Results from the Dutch Common Channel Trial (DUCATI): Superior Weight Loss Results of the Long Roux Limb Gastric Bypass in Comparison to the Standard Bypass at 3-Year Follow-Up.

In the multi-center Dutch Common Channel Trial (DUCATI), a very long Roux limb Roux-en-Y gastric bypass (VLRL-RYGB: BP-limb 60 cm, Roux limb variable, and common channel 100 cm) was compared to a standard Roux-en-Y gastric bypass (S-LRYGB: BP-limb 60 cm, Roux limb 150 cm, and common channel variable) in the treatment of morbidly obese patients. As all trial patients are beyond 3-year follow-up a midterm analysis was performed to investigate the effect of the VLRL-RYGB. METHODS: A total of 444 patients were randomized (1:1) to receive either a VLRL-RYGB or a S-LRYGB. Follow-up results for weight loss, effect on obesity-related comorbid conditions, complications, reoperation, and malnutrition are investigated. RESULTS: At 3-year follow-up a significant difference in %TWL (34.0% vs. 31.4%, p = 0.017) and %EWL (84.7% vs. 76.6%, p = 0.043) was observed in favor of VLRL-LRYGB group. Overall complication rate 3-years after surgery was 15.8% in the VLRL-LRYGB group vs. 9% in the S-LRYGB group (p = 0.031). Eight (3.6%) patients in the VLRL-LRYGB group versus 2 (0.9%) in the S-LRYGB group (p = 0.055) required revisional surgery for malabsorption. In the VLRL-LRYGB group 71.9% of patients had resolution of T2DM versus 48.9% in the S-LRYGB group (p = 0.044). CONCLUSION: At midterm FU a considerable, significantly increased effect on weight loss of the VLRL-LRYGB was observed compared to the S-LRYGB, with a higher risk of overall complications, but no significant nutritional side effects. These results might impact the current view on the value of the Roux limb in the discussion on optimum limb lengths in Roux-en-Y gastric bypass surgery.

Conservative management of acute appendicitis in the era of COVID 19: A multicenter prospective observational study at the United Arab Emirates.

BACKGROUND & AIMS: Since its emergence in December 2019, the COVID-19 pandemic resulted in a profound impact on the health care system worldwide. We propose herein to evaluate the impact of implementing conservative management as an alternative approach to surgical appendectomy during COVID19 pandemic. MATERIALS AND METHODS: Our study is a prospective multicenter study that includes a cohort of 158 patients admitted to the surgical departments in both Tawam Hospital and SSMC hospital, Abu Dhabi, UAE, from February 2020 till July 2020. RESULTS: Our results showed a significant decrease in length of hospital stay (LOS) (2.32 ± 0.83 days) among conservatively treated group compared to the surgically treated group (2.8 ± 1.47 days). Also, short term follow-up showed that 90% of those patients did not require further operative intervention or developed complications. Out of the 110 patients that were swapped for COVID19, nine (8.18%) were confirmed to be positive. Our protocol was to avoid surgical management for COVID19 positive patients unless indicated. This resulted in (8/9) of COVID19 positive patients to be treated conservatively. CONCLUSIONS: In conclusion, our results showed that the implementation of conservative management in treating patients with acute appendicitis who were COVID19 positive maybe essential in reducing viral transmission risks as well as avoiding operative risks on COVID19 positive patients.

First Successful Large-Scale Introduction of an Enhanced Recovery after Bariatric Surgery (ERABS) Program in the Middle East: The Results and Lessons Learned of Tawam Hospital/Johns Hopkins, a Tertiary Governmental Center in the UAE.

BACKGROUND: Although enhanced recovery after bariatric surgery (ERABS) has proven to be safe and cost-effective, this concept is relatively new in the Middle East. METHODS: A retrospective analysis of consecutive registered cohorts of patients who underwent primary and purely laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) were compared before introduction of ERABS (2010-2014) and after ERABS (2015-2017) at Tawam Hospital/Johns Hopkins, the UAE. RESULTS: A total of 462 eligible bariatric patients (LSG 414 and LRYGB 48) were operated on before and 1602 (LSG 1436 and LRYGB 166) after introduction of the ERABS. Significant improvements of mean patient time of the patient being within the OR for LSG (from 2:27 to 1:23 min, p = 0.000) and LRYGB (from 3:17 to 1:59 min, p = 0.000) were achieved when comparing pre-ERABS with after introduction of ERABS. Furthermore, there was a significant decrease in LOS in both LSG (from 3.2 to 1.5 days, p = 0.000) and in LRYGB (from 3.5 to 1.7 days, p = 0.000). Major (CD classification III-IV) complications decreased significantly in LSG (from 13.8 to 0.8%, p = 0.000) and were similar in LRYGB (from 4.2% to 3.0%, p = NS). The readmission rate for LSG (from 2.9 to 2.6%, p = NS) or LRYGB (from 0 to 4.8%, p = NS) and the reoperation rates after LSG (from 0.7 to 0.5%, p = NS) and LRYGB (from 0 to 2.4%, p = NS) did not differ between both groups following introduction of ERABS. CONCLUSIONS: Implementation of a standardized ERABS program in the Middle East is feasible and safe and leads to reduced LOS and OR times.

The effect of sex and menopause on carotid intima-media thickness and pulse wave velocity in morbid obesity.

BACKGROUND: Women are relatively protected from cardiovascular disease compared with men. Since morbid obesity is an independent risk factor for cardiovascular disease, the current study investigated whether the association between sex and cardiovascular risk factors and outcomes can be demonstrated in subjects suffering from morbid obesity. MATERIALS AND METHODS: Two hundred subjects enrolled in a study on cardiovascular risk factors in morbid obesity underwent extensive laboratory screening, carotid intima-media thickness (cIMT) and pulse wave velocity (PWV) measurements. Gender differences were analysed using univariate and multivariable linear regression models. In addition, the effect of menopause on cIMT and PWV was analysed. Results of these models were reported as B coefficients with 95% confidence intervals. RESULTS: The group consisted of 52 men and 148 women, with a mean age of 41 (±11.8) years and a mean body mass index (BMI) of 42.7 (±5.2) kg/m2 . Both, cIMT and PWV were significantly higher in men than in women, although the difference in cIMT disappeared after adjustment for covariables such as waist circumference, age, high-density lipoprotein cholesterol and mean arterial pressure. PWV was associated with sex after adjustments for covariables in morbidly obese patients. Postmenopausal women had significantly increased cIMT and PWV when compared with premenopausal women. CONCLUSION: Sex differences in PWV persist in subjects suffering from morbid obesity. However, no difference was found in cIMT between morbidly obese men and women after adjustment for classic cardiovascular risk factors. Premenopausal morbidly obese women are protected for cardiovascular disease when compared with postmenopausal morbidly obese women.

Discrepancies Between BMI and Classic Cardiovascular Risk Factors.

BACKGROUND: Obesity is related to increased cardiovascular risk. It is unknown whether increasing levels of obesity also increase levels of cardiovascular risk factors and systemic inflammation. This study describes the relationship between classic cardiovascular risk factors and inflammatory markers with BMI in a group of obese and non-obese subjects. MATERIALS AND METHODS: Obese subjects (BMI ≥ 30 kg/m2; n = 576; mean ± SD BMI 43.8 ± 7.58 kg/m2) scheduled for bariatric surgery were included. The reference population consisted of non-obese volunteers (BMI < 30 kg/m2; n = 377, BMI 25.0 ± 2.81 kg/m2). The relationship between BMI quintiles and the levels of cardiovascular risk factors was analyzed. Adipose tissue volumetry was performed in 42 obese subjects using abdominal CT scans. RESULTS: The obese group included more women and subjects with type 2 diabetes mellitus, hypertension, and current smoking behavior. In obese subjects, HDL-C and triglycerides decreased with increasing BMI. Systolic and diastolic blood pressure, total cholesterol, LDL-C, and apoB were not related to BMI in the obese group, in contrast to the non-obese group. Inflammatory markers CRP, leukocyte count, and serum complement C3 increased with increasing BMI in the obese group, while these relations were less clear in the non-obese group. The subcutaneous adipose tissue surface was positively correlated to BMI, while no correlation was observed between BMI and visceral adipose tissue. CONCLUSIONS: Markers of inflammation are strongest related to BMI in obese subjects, most likely due to increased adipose tissue mass, while cardiovascular risk factors do not seem to deteriorate above a certain BMI level. Limited expansion capacity of visceral adipose tissue may explain these findings.

Contribution of Type 2 Diabetes Mellitus to Subclinical Atherosclerosis in Subjects with Morbid Obesity.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) and obesity are both related to increased risk of cardiovascular disease and mortality. Early atherosclerotic vascular changes can be detected by non-invasive tests like carotid artery intima-media thickness (cIMT) and pulse wave velocity (PWV). Both cIMT and PWV are significantly impaired in T2DM patients and in obese patients, but the additional effect of T2DM on these vascular measurements in obese subjects has not been evaluated. METHODS: Two hundred morbidly obese patients with or without T2DM were enrolled in a prospective cohort study and underwent extensive laboratory testing, including cIMT and PWV measurements. The cohort was divided into a group with and a group without T2DM. RESULTS: Within this cohort, 43 patients (21.5%) were diagnosed with T2DM. These patients were older and had more often (a history of) hypertension as compared to patients without T2DM. HbA1c levels were significantly increased, while LDL cholesterol was significantly lower and the use of statins higher than in non-diabetic participants. cIMT and PWV were significantly increased in subjects suffering from T2DM. The variability in cIMT and PWV was related to differences in age and systolic blood pressure, but not to the presence of T2DM. CONCLUSION: While T2DM negatively affects the vasculature in morbid obesity, hypertension and age seem to be the major risk factors, independent from the presence of T2DM. CLINICAL TRIAL REGISTRATION: Dutch Trial Register NTR5172 .

The Standardized Postoperative Checklist for Bariatric Surgery; a Tool for Safe Early Discharge?

BACKGROUND: Morbidly obese patients are at higher risk of complications after surgery. In bariatric surgery, pre- and intra-operative checklists are commonly used to identify high-risk patients preoperatively, to decrease the number of postoperative complications. This pilot study evaluates the effect of a postoperative checklist in bariatric surgery, addressing regularly measured parameters, on the occurrence and early recognition of complications. METHODS: An in-house developed postoperative checklist was used on the first postoperative day after bariatric surgery and included information on nausea, pain, temperature, heart rate, and laboratory markers. Complications were scored using the Clavien-Dindo (CD) classification, and three groups were formed: no complications (CD0), minor complications (CD1 and 2), and major complications (≥CD3a). Differences between groups were analyzed using nonparametric tests. RESULTS: Six hundred ninety-four subjects were included (79.5% female, age 42.6 ± 10.8 years, BMI 43.8 ± 5.8 kg/m2). Twenty-nine subjects developed major complications within 30 days postoperatively. There were no significant differences in baseline characteristics between groups. Subjects with major complications were less willing to be discharged due to complaints, compared to subjects with no or minor complications (14.8 vs. 3.6 and 4.6%, respectively) and had a higher decrease of hemoglobin level (0.8 vs. 0.6 and 0.65 mmol/l, respectively). CONCLUSION: The patient's willingness for discharge, in combination with hemoglobin decrease, may be the best early predictors of major complications after bariatric surgery. This postoperative checklist may be an adequate instrument to identify patients who can be safely discharged home on the first postoperative day and thereby play a part in patient management after bariatric surgery.

Quality of Life 1 Year After Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Roux-en-Y Gastric Bypass: a Randomized Controlled Trial Focusing on Gastroesophageal Reflux Disease.

INTRODUCTION: Bariatric surgery is the only treatment option that achieves sustained weight loss in obese patients and that also has positive effects on obesity-related comorbidities. Laparoscopic sleeve gastrectomy (LSG) seems to achieve equal weight loss as laparoscopic Roux-en-Y gastric bypass (LRYGB), but there is still much debate about the quality of life (QOL) after LSG, mainly concerning the association with gastroesophageal reflux. Our hypothesis is that QOL after LSG is comparable with QOL after LRYGB. MATERIALS AND METHODS: Between February 2013 and February 2014, 150 patients were randomized to undergo either LSG or LRYGB in our clinic. Differences in QOL were compared between groups by using multiple QOL questionnaires at follow-up moments preoperatively and 2 and 12 months after surgery. RESULTS: After 12 months of follow-up, 128 patients had returned the questionnaires. Most QOL questionnaires showed significant improvement in scores between the preoperative moment and after 12 months of follow-up. The Gastroesophageal Reflux Disease Questionnaire (GerdQ) score deteriorated in the LSG group after 2 months, but recovered again after 12 months. After 2 months of follow-up, the mean GerdQ score was 6.95 ± 2.14 in the LSG group versus 5.50 ± 1.49 in the LRYGB group (p < 0.001). After 1 year, the mean GerdQ score was 6.63 ± 2.26 in the LSG group and 5.60 ± 1.07 in the LRYGB group (p = 0.001). CONCLUSION: This randomized controlled trial shows that patients who underwent LSG have significantly higher GerdQ scores at both 2 and 12 months postoperatively than patients who underwent LRYGB, whereas overall QOL did not differ significantly.

Long-Term Results of Laparoscopic Sleeve Gastrectomy for Morbid Obesity: 5 to 8-Year Results.

INTRODUCTION: Although long-term results of sleeve gastrectomy (LSG) remain scarce in the literature, its popularity as a stand-alone procedure has accounted for a global increase in LSG performance. In this retrospective study, the authors present 5 to 8-year follow-up results in terms of weight loss, failure/revision rate, and comorbidity resolution from a single center. MATERIALS AND METHODS: A prospectively maintained database was reviewed for patients who underwent LSG between 2007 and 2010. Data analysis on weight loss, comorbid conditions, revision surgery, and mortality was conducted. RESULTS: Median percentage excess BMI loss (%EBMIL) was 59.0, and 53.9 %, and median percentage total weight loss (%TWL) was 25.1, and 22.9 % at 5 and 8 years, respectively. Revision to gastric bypass due to insufficient weight loss or gastroesophageal reflux disease (GERD) was performed in 42 patients (15.2 %). Resolution of comorbid condition was achieved in 91 % of patients with obstructive sleep apnea syndrome (OSAS), 68 % of patients with type 2 diabetes (T2DM), 53 % of patients with hypertension, and 25 % of patients with dyslipedemia. Loss to follow-up rate was 45 % at 5 years, 28 % at 6 years, 23 % at 7 years, and 13 % at 8 years. CONCLUSION: This study adds to the currently available data confirming the LSG to be a safe and effective procedure at long term. Data from high-volume studies are needed to establish the definite role of the LSG in the spectrum of bariatric procedures.

Results of Implementing an Enhanced Recovery After Bariatric Surgery (ERABS) Protocol.

BACKGROUND: With the increasing prevalence of morbid obesity and healthcare costs in general, interest is shown in safe, efficient, and cost-effective bariatric care. This study describes an Enhanced Recovery After Bariatric Surgery (ERABS) protocol and the results of implementing such protocol on procedural times, length of stay in hospital (LOS), and the number of complications, such as readmissions and reoperations. METHODS: Results of implementing an ERABS protocol were analyzed by comparing a cohort treated according to the ERABS protocol (2012-2014) with a cohort treated before implementing ERABS (2010-2012). Differences between both cohorts were analyzed using independent t tests and chi-squared tests. RESULTS: A total of 1.967 patients (mean age 43.3 years, 80% female) underwent a primary bariatric procedure between 2010 and 2014, of which 1.313 procedures were performed after implementation of ERABS. A significant decrease of procedural times and a significantly decreased LOS, from 3.2 to 2.0 nights (p < 0.001), were seen after implementation of ERABS. Significantly more complications were seen post-ERABS (16.1 vs. 20.7%, p = 0.013), although no significant differences were seen in the number of major complications. CONCLUSION: Implementation of ERABS can result in shorter procedural times and a decreased LOS, which may lead to more efficient and cost-effective bariatric care. The increase in complications was possibly due to better registration of complications. The main goal of an ERABS protocol is efficient, safe, and evidence-based bariatric care, which can be achieved by standardization of the total process.

The Sleeve Bypass Trial: a multicentre randomized controlled trial comparing the long term outcome of laparoscopic sleeve gastrectomy and gastric bypass for morbid obesity in terms of excess BMI loss percentage and quality of life.

BACKGROUND: Obesity is an increasing disease worldwide. Bariatric surgery is the only effective therapy to induce sufficient long-term weight loss for morbidly obese patients. Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold standard surgical technique. Laparoscopic Sleeve Gastrectomy (LSG) is a new promising bariatric procedure which has the advantage of maintaining an intact gastrointestinal tract. The aim of this study is to evaluate the efficiency of both techniques. Our hypothesis is that LSG has a similar percentage excess BMI loss (%EBMIL) after 5 years compared to LRYGB. METHODS/DESIGN: The Sleeve Bypass Trial is a randomized multicentre clinical trial: patients eligible for bariatric surgery are randomized to either LSG or LRYGB. Patients with a body mass index (BMI) ≥ 40 kg/m(2) or BMI 35 kg/m(2) with obesity related comorbidity (T2 DM, sleep apnoea, hypertension) are eligible for randomization. At randomization patients are stratified for centre, sex, T2 DM and BMI ≥ 50 kg/m(2). A total number of 620 patients will be enrolled and equally (1:1) randomized to both treatment arms. Only surgeons experienced in both operation techniques will participate in the Sleeve Bypass trial. The primary endpoint is the 5-year weight loss (%EBMIL) of LSG and LRYGB. Secondary endpoints are resolution of obesity related comorbidity, complications, revision bariatric surgery and quality of life (QOL) defined in various questionnaires. DISCUSSION: Long-term %EBMIL between the two treatment strategies used to be in favour of LRYGB, but more recent results throughout the world show similar %EBMIL in both techniques. If weight loss is comparable, obesity-related comorbidity and QOL after bariatric procedures should be taken into account when deciding on which surgical technique is to be preferred for certain subgroups in the future. TRIAL REGISTRATION: Dutch Trial Register: NTR 4741.

Study protocol of the DUCATI-study: a randomized controlled trial investigating the optimal common channel length in laparoscopic gastric bypass for morbid obese patients.

BACKGROUND: Morbid obesity has become one of the most frequent chronic medical disorders in Western countries, affecting 1.5-2 % of the Dutch population. Currently, the laparoscopic Roux-Y gastric bypass is considered to be the most effective bariatric treatment option for morbid obesity as it results in adequate weight loss and a significant decrease in comorbidity. Although this technique has been applied for years, the optimal lengths of the three bowel limbs (alimentary limb, biliopancreatic limb, and common channel) in order to achieve maximal percentage excess weight loss with minimal side effects (i.e. malabsorption symptoms), are unknown. As 'normal' sized gastric bypasses achieve an average of 60 - 80 % excess weight loss after one year, one could hypothesize that afferent limb lengths should be longer in order to reduce the common channel length, thereby improving outcome in terms of excess weight loss. The aim of the current study is to investigate the effect of the length of the common channel in gastric bypass surgery for morbid obesity. In this randomized controlled trial the very long Roux limb gastric bypass will be compared to the standard gastric bypass, in order to conclude which option is the optimal therapeutic strategy in the morbidly obese patient. METHODS/DESIGN: In this multicentre trial patients will be randomized either to a very long Roux limb gastric bypass with a fixed common channel length of 100 cm, or to a standard gastric bypass with a variable common channel length. The primary objective is to evaluate whether the very long Roux limb gastric bypass is superior in terms of percentage excess weight loss after one year follow-up compared to the standard gastric bypass. Secondary endpoints are quality-of-life, cure /improvement of obesity related comorbidity, complications, malnutrition, re-admission rate, and re-operation rate. DISCUSSION: We hypothesize that our proposed distal LRYGB will provide for improved results concerning % EWL with an acceptable rate of (metabolic) complications. Our main point of interest is to determine if the distal LRYGB is a superior alternative to standard LRYGB in terms of percentage excess weight loss and to put more focus on the role of the common channel. Therefore we will perform this randomized controlled trial comparing both techniques, with % EWL as a primary outcome. TRIAL REGISTRATION: CCMO registration number: NL43951.101.13 and Netherlands Trial Registry number: NTR4466.

Impact of the European Working Time Directive (EWTD) on the operative experience of surgery residents.

BACKGROUND: In Europe and the United States, work hour restrictions are considered to be particularly burdensome for residents in surgery specialties. The aim of this study was to examine whether reduction of the work week to 48 hours resulting from the implementation of the European Working Time Directive has affected the operative experience of surgery residents. METHODS: This study was conducted in a general surgery training region in the Netherlands, consisting of 1 university hospital and 6 district training hospitals. Operating records summarizing the surgical procedures performed as "primary surgeon" in the operating theater for different grades of surgeons were retrospectively analyzed for the period 2005-2012 by the use of linear regression models. Operative procedures performed by residents were considered the main outcome measure. RESULTS: In total, 235,357 operative procedures were performed, including 47,458 (20.2%) in the university hospital and 187,899 (79.8%) in the district training hospitals (n = 5). For residents in the university hospital, the mean number of operative procedures performed per 1.0 full-time equivalent increased from 128 operations in 2005 to 204 operations in 2012 (P = .001), whereas for residents in district training hospitals, no substantial differences were found over time. The mean (±SD) operative caseload of 64 residents who completed the 6-year training program between 2005 and 2012 was 1,391 ± 226 (range, 768-1856). A comparison of the operative caseload according to year of board-certification showed no difference. CONCLUSION: Implementation of the European Working Time Directive has not affected adversely the number of surgical procedures performed by residents within a general surgical training region in the Netherlands.

Effectiveness and Safety of Sleeve Gastrectomy, Gastric Bypass, and Adjustable Gastric Banding in Morbidly Obese Patients: a Multicenter, Retrospective, Matched Cohort Study.

BACKGROUND: Laparoscopic adjustable gastric band (LAGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most performed procedures worldwide (92 %) nowadays. However, comparative clinical trials are scarce in literature. The objective of this study was to compare the effectiveness and safety of the three most performed bariatric procedures. METHODS: A multicenter, retrospective, matched cohort study was conducted. Patients were eligible for analysis when a primary procedure was performed between 2007 and 2010 in one of the two specialized bariatric centers. Primary outcome was weight loss, expressed in the percentage excess weight loss (%EWL). Secondary outcome parameters are hospital stay, complication rate, and revisional surgery. RESULTS: In total, 735 patients, 245 in each group, were included for analysis. The groups were comparable for age and gender after matching. Mean postoperative follow-up was 3.1 ± 1.2 years. LAGB patients showed less %EWL compared to LSG and LRYGB at all postoperative follow-up visits. LRYGB showed a %EWL of 71 ± 20 % compared to LSG (76 ± 23 %; p=0.008) after 1-year follow-up; thereafter, no significant difference was observed. After 3 years of follow-up, LAGB showed a higher complication rate compared to LSG and LRYGB (p<0.05). Revisional surgery after LAGB was needed in 21 %, while 9 % of the LSG underwent conversion to RYGB. CONCLUSIONS: LRYGB is a safe and effective treatment in morbid obese patients with good long-term outcomes. LSG seems to be an appropriate alternative as a definitive procedure, in terms of weight reduction and complication rate. LAGB is inferior to both LRYGB and LSG.

The use of negative-pressure wound therapy in pilonidal sinus disease: a randomized controlled trial comparing negative-pressure wound therapy versus standard open wound care after surgical excision.

BACKGROUND: Pilonidal sinus disease is associated with significant morbidity after surgical treatment with regard to wound healing. Recent case studies suggested that negative-pressure wound therapy as primary treatment following surgical excision may shorten the duration of wound healing. OBJECTIVE: The purpose of this randomized controlled trial was to evaluate the role of vacuum therapy in pilonidal sinus disease: negative-pressure wound therapy versus standard open wound care after surgical excision. METHODS: Patients were randomly assigned to either negative-pressure wound therapy for 2 weeks or standard open wound healing. The primary end point of the study was the time to complete wound healing. Secondary end points were visual analog scale score, wound size ratio at day 14 (ie, wound healing rate), time to resume daily activities, and recurrence within 6 months after wound closure. RESULTS: Forty-nine patients were included in the study: 24 patients were treated with vacuum therapy, and 25 patients underwent standard open wound care. Complete wound healing was achieved at a median of 84 days in the vacuum therapy group versus 93 days in control patients (p = 0.44). The wound size ratio was significantly lower in the vacuum therapy group (0.30 versus 0.57, p = 0.02), ie, higher wound healing rate in the first 2 weeks. There was no difference in visual analog scale scores and disease recurrence between both groups. The time to resume full daily activities after surgery was 27 days in the patients undergoing vacuum therapy and 29 days in the control patients (p = 0.92). LIMITATIONS: This study is limited by the small number of patients, the lack of blinding to patients and doctors, and the absence of patient quality-of-life evaluation. CONCLUSION: It is feasible to apply vacuum therapy in the treatment of pilonidal sinus disease, and it has a positive effect on wound size reduction in the first 2 weeks. However, there is no difference in time to complete wound healing and time to resume daily life activities.

Assessment of surgery residents' operative skills in the operating theater using a modified Objective Structured Assessment of Technical Skills (OSATS): a prospective multicenter study.

BACKGROUND: With the implementation of competency-based curricula, Objective Structured Assessment of Technical Skills (OSATS) increasingly is being used for the assessment of operative skills. Although evidence for its usefulness has been demonstrated in experimental study designs, data supporting OSATS application in the operating room are limited. This study evaluates the validity and reliability of the OSATS instrument to assess the operative skills of surgery residents in the operating theater. METHODS: Twenty-four residents were recruited from seven hospitals within a general surgical training region and classified equally into three groups according to postgraduate training year (PGY). Each resident had to perform five different types of operations. Surgical performance was measured using a modified OSATS consisting of three scales: Global Rating Scale, Overall Performance Scale, and Alphabetic Summary Scale. Validity and reliability metrics included construct validity (Kruskal-Wallis test) and internal consistency reliability (Cronbach's α coefficient). Spearman's correlation coefficients were calculated to determine correlations between the different scales. RESULTS: Eighteen residents (PGY 1-2 [n = 7]; PGY 3-4 [n = 8]; PGY 5-6 [n = 3]) performed 249 operations. Comparisons of the performance scores revealed that evidence for construct validity depended on the difficulty level of the selected procedures. For individual operations, internal consistency reliability of the Global Rating Scale ranged from 0.93 to 0.95. Scores on the different scales correlated strongly (r = 0.62-0.76, P < .001). CONCLUSION: Assessment of operative skills in the operating theater using this modified OSATS instrument has the potential to establish learning curves, allowing adequate monitoring of residents' progress in achieving operative competence. The Alphabetic Summary Scale seems to be of additional value. Use of the Overall Performance Scale should be reconsidered.