Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass).

Background: Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects. Methods: This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was -13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900. Findings: 628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%-63%] after sleeve gastrectomy and 67.1% [95% CI, 63%-71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, -12.5% to -4.0%]). This was within the predefined margin (P < 0.001). Total weight loss at 5 years was 22.5% [95% CI, 20.7%-24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%-27.8%] after Roux-en-Y gastric bypass (difference 3.5% [95% CI, -5.2% to -1.7%]). In both groups, obesity-related comorbidities significantly improved after 5 years. Dyslipidaemia improved more frequently after Roux-en-Y gastric bypass (83%, 54/65) compared to sleeve gastrectomy (62%, 44/71) (P = 0.006). De novo gastro-oesophageal reflux disease occurred more frequently after sleeve gastrectomy (16%, 46/288) vs Roux-en-Y gastric bypass (4%, 10/280) (P < 0.001). Minor complications were more frequent after Roux-en-Y gastric bypass (5%, 15/316) compared to sleeve gastrectomy (2%, 5/312). No statistically significant differences in major complications and health-related quality of life were encountered. Interpretation: In people living with obesity grades 2 and 3, sleeve gastrectomy and Roux-en-Y gastric bypass had clinically comparable excess BMI loss according to the predefined definition for equivalence. However, Roux-en-Y gastric bypass showed significantly higher total weight loss and significant advantages in secondary outcomes, including dyslipidaemia and GERD, yet at a higher rate of minor complications. Major complications, other comorbidities, and overall HRQoL did not significantly differ between the groups. Funding: Not applicable.

Nissen-Sleeve procedure versus laparoscopic Roux-en-Y gastric bypass in patients with morbid obesity and gastro-oesophageal reflux disease: protocol for a non-inferiority randomised trial (GINSBY).

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most frequently performed procedures in bariatric surgery. In patients with morbid obesity and gastro-oesophageal reflux disease (GORD), LRYGB is the most accepted procedure. For patients with a contraindication for LRYGB or a strong preference for LSG, the Nissen-Sleeve procedure may be a viable new option. The aim of this study is to compare effectiveness of Nissen-Sleeve with LRYGB. METHOD AND ANALYSIS: This is a single-centre, phase III, parallel-group randomised controlled trial in a high-volume bariatric centre in the Netherlands. A total of 88 patients with morbid obesity and GORD will be randomised to evaluate non-inferiority of Nissen-Sleeve versus LRYGB (non-inferiority margin 15%, power 80%, one-sided α 0.025, 9% drop out). Patients with morbid obesity aged 18 years and older with GORD according to the Montreal definition will be included after obtaining informed consent. Exclusion criteria are achalasia, neoplastic abnormalities diagnosed during endoscopy, super obesity (body mass index ≥50 kg/m2), Crohn's disease and medical history of major abdominal surgery. After randomisation, all patients will undergo an upper gastrointestinal endoscopy. Patients in the Nissen-Sleeve arm will undergo a timed barium oesophagram to exclude oesophageal motility disorders. Patients will complete six questionnaires at baseline and every year until 5 years of follow-up. At day 1 postoperative, patients in the Nissen-Sleeve arm will undergo a swallow X-ray to confirm passage. At 1 year, all patients will undergo another endoscopy. The primary outcome is GORD status. Absence of GORD is defined as <8 points on the GORD questionnaire. Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 15 September 2021. Written informed consent will be obtained for all participants in the study. The study results will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NL9789; The Netherlands Trial Registry.

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.

Effects of Morbid Obesity and Metabolic Syndrome on the Composition of Circulating Immune Subsets.

Morbid obesity is characterized by chronic, low-grade inflammation, which is associated with 'inflamm-aging'. The presence of metabolic syndrome (MetS) might accelerate this phenomenon of metaflammation. In this study, we assessed the effects of morbid obesity and MetS on the composition of a broad spectrum of immune cells present within the circulation. A total of 117 morbidly obese patients (MOP) without MetS (MetS-), 127 MOP with MetS (MetS+) and 55 lean controls (LC) were included in this study. Absolute numbers of T cell, B cell, NK cell and monocyte subsets were assessed within peripheral blood using flow cytometry. Both absolute cell numbers and proportion of cells were evaluated correcting for covariates age, body mass index and cytomegalovirus serostatus. Although the absolute number of circulating CD4+ T cells was increased in the MetS+ group, the CD4+ T cell composition was not influenced by MetS. The CD8+ T cell and B cell compartment contained more differentiated cells in the MOP, but was not affected by MetS. Even though the absolute numbers of NK cells and monocytes were increased in the MOP as compared to LC, there was no difference in proportions of NK and monocyte subsets between the three study groups. In conclusion, although absolute numbers of CD4+ and CD8+ T cells, B cells, NK cells and monocytes are increased in MOP, obesity-induced effects of the composition of the immune system are confined to a more differentiated phenotype of CD8+ T cells and B cells. These results were not affected by MetS.

Reducing complication rates and hospital readmissions while revising the enhanced recovery after bariatric surgery (ERABS) protocol.

BACKGROUND: To optimize the postoperative phase following bariatric surgery, the enhanced recovery after bariatric surgery pathway (ERABS) has been developed. The aim of ERABS is to create a care path that is as safe, efficient and patient-friendly as possible. Continuous evaluation and optimization of ERABS are important to ensure a safe treatment path and may result in better outcomes. The objective of this study was to compare the clinical outcomes of patients undergoing bariatric surgery over 2014-2017, during which the ERABS protocol was continuously evaluated and optimized. METHODS: This is a retrospective cohort study. Data were collected from patients undergoing a primary Roux-en-Y gastric bypass or sleeve gastrectomy between January 2014 and December 2017. Outcomes were early complications, unplanned hospital revisits, readmissions, duration of surgery and length of hospital stay. RESULTS: 2889 patients underwent a primary bariatric procedure in a single center. There was a significant decrease in minor complications over the years from 7.0 to 1.9% (p < 0.001). Hospital revisit rates decreased after 2015 (p < 0.001). Readmission rates decreased over time (p < 0.001). The mean duration of surgery decreased from 52 (in 2014) to 41 (in 2017) minutes (p < 0.001). Median length of hospital stay decreased from 1.8 to 1.5 days in 2015 (p = 0.002) and remained stable since. CONCLUSION: An improvement of the ERABS protocol was associated with a decrease in minor complication rates, number of unplanned hospital revisits and readmission rates after primary bariatric procedures.

Low-pressure pneumoperitoneum with deep neuromuscular blockade in metabolic surgery to reduce postoperative pain: a randomized pilot trial.

BACKGROUND: For metabolic laparoscopic surgery, higher pressures up to 20 mmHg are often used to create a surgical field of sufficient quality. This randomized pilot study aimed to determine the feasibility, safety and tolerability of low intraabdominal pressure (IAP) and deep neuromuscular blockade (NMB) to reduce postoperative pain. METHODS: In a teaching hospital in the Netherlands, 62 patients eligible for a laparoscopic Roux-en-Y gastric bypass (LRYGB) were randomized into one of four groups in a 2 × 2 factorial design: deep/moderate NMB and standard (20 mmHg)/low IAP (12 mmHg). Patient and surgical team were blinded. Primary outcome measure was the surgical field quality, scored on the Leiden-Surgical Rating Scale (L-SRS). Secondary outcome measures were (serious) adverse events, duration of surgery and postoperative pain. RESULTS: 62 patients were included. L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB. In 40% of patients with low IAP and deep NMB, an increase in IAP was needed to improve surgical overview. In patients with low IAP and moderate NMB, IAP was increased to improve surgical overview in 40%, and in 75% of these cases a deep NMB was requested to further improve the surgical overview. Median duration of surgery was 38 min (IQR34-40 min) in the group with standard IAP and moderate NMB and 52 min (IQR46-55 min) in the group with low IAP and deep NMB. CONCLUSIONS: The combination of moderate NMB and low IAP can create insufficient surgical overview. Larger trials are needed to corroborate the findings of this study. TRIAL REGISTRATION: Dutch Trial Register: Trial NL7050, registered 28 May 2018. https://www.trialregister.nl/trial/7050 .

Does the Length of the Common Channel as Part of the Total Alimentary Tract Matter? One Year Results from the Multicenter Dutch Common Channel Trial (DUCATI) Comparing Standard Versus Distal Roux-en-Y Gastric Bypass with Similar Biliopancreatic Bowel Limb Lengths.

PURPOSE: Although the laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold-standard bariatric procedure, it remains uncertain what the optimal bowel limb lengths are to accomplish maximal weight loss while minimizing nutritional deficiencies and related gastro-intestinal complaints. The aim of this randomized controlled multicenter trial is to investigate the effect of significant lengthening of the length of the Roux limb (RL) at the cost of the length of the common channel (CC) while keeping the biliopancreatic limb (BPL) lengths the same on both study arms. METHODS: Four hundred forty-four patients were randomized to receive either a Very Long Roux Limb LRYGB (VLRL-LRYGB) (variable RL length, BPL 60 cm, and CC 100 cm) or a Standard LRYGB (S-LRYGB) (RL 150 cm, BPL 60 cm, and a variable CC length). Results at 1-year follow-up for weight loss, effect on obesity-related comorbid conditions, complications, re-operation rate, malnutrition rate, and re-admission rate were investigated. RESULTS: Weight loss at 1-year showed no significant differences for %EWL (84.3% versus 85.3%, p = 0.72) and %TWL (34.2% versus 33.6%, p = 0.359) comparing VLRL-LRYGB versus S-LRYGB. Malabsorption requiring surgical bowel length adjustment was observed in 1.4% in VLRL-LRYGB group versus 0.9% in S-LRYGB group (p = 0.316). CONCLUSION: Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL. Nevertheless, long-term results of the VLRL-LRYGB have to be awaited to draw final conclusions as part of the discussion towards optimal limb length in LRYGB surgery.

Correction to: One anastomosis gastric bypass vs. Roux-en-Y gastric bypass, remedy for insufficient weight loss and weight regain after failed restrictive bariatric surgery.

In the original article there was a discrepancy between the XML (online) version of the article and the PDF.

One anastomosis gastric bypass vs. Roux-en-Y gastric bypass, remedy for insufficient weight loss and weight regain after failed restrictive bariatric surgery.

BACKGROUND: Failure occurs in up to 60% of the patients that were treated with primary restrictive bariatric operations such as Laparoscopic Adjustable Gastric Banding (LAGB), or restrictive/metabolic operations like Laparoscopic Sleeve Gastrectomy (LSG). Insufficient weight loss and weight regain are the most commonly reported reasons of failure. The aim of this retrospective multicenter study was to compare One Anastomosis Gastric Bypass (OAGB) to Roux-en-Y Gastric Bypass (RYGB) as a revisional procedure in terms of weight loss, procedure time, complication rate and morbidity. METHODS: 491 patients operated on between 2012 and 2017 for failed restrictive surgery were included in this study (OAGB (n=185) or RYGB (n=306)). Failure was defined as total weight loss (TWL) less than 25%, excess weight loss (EWL) less than 50% and/or a remaining body mass index (BMI) larger than 40 kg/m2 at two years of follow up. Primary outcome measures were %TWL and % excess BMI loss (EBMIL) at 12, 24 and 36 months of follow-up. Secondary outcomes were procedure time, reduction of comorbidity, early and late complication rate, and mortality. RESULTS: %TWL was significantly larger in the OAGB group at 12 months (mean 24.1±9.8 vs. 21.9±9.7, p = 0.023) and 24 months (mean 23.9±11.7 vs. 20.5±11.2, p = 0.023) of follow-up. %EBMIL was significantly larger in the OAGB group at 12 months (mean 69.0±44.6 vs. 60.0±30.1, p = 0.014) and 24 months (mean 68.6±51.6 vs. 56.4±35.4, p = 0.025) of follow-up. Intra-abdominal complications (leakage, bleeding, intra-abdominal abscess and perforation) occurred less frequently after revisional OAGB (1.1% vs. 4.9%, p = 0.025). Surgical intervention for biliary reflux (5.4% vs. 0.3%, p < 0.001) was more prevalent in the OAGB group. Surgical intervention for internal herniation (0.0% vs. 4.9%, p = 0.002) was more prevalent in the RYGB group. CONCLUSIONS: This study suggests that OAGB is superior to RYGB as a remedy for insufficient weight loss and weight regain after failed restrictive surgery with more weight loss and a lower early complication rate. To substantiate these findings, further research from prospective randomized controlled trials is needed.

Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial.

INTRODUCTION: Fast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). METHODS AND ANALYSIS: This is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE. ETHICS AND DISSEMINATION: The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations. TRIAL REGISTRATION NUMBER: The Netherlands Trial Registry (NL8029); Pre-results.

Structural and functional vascular improvement 1 year after bariatric surgery: a prospective cohort study.

BACKGROUND: Obesity is a major risk factor for cardiovascular disease. Data on structural and functional arterial changes after bariatric surgery are scarce. OBJECTIVES: The aim of this study was to determine the effects of bariatric surgery on the carotid intima media thickness (cIMT) and pulse wave velocity (PWV). SETTING: General hospital. METHODS: We collected data prospectively in 200 patients scheduled for bariatric surgery between 2015-2017. Based on an increase or decrease of 1 standard deviation of the mean difference in cIMT and PWV 1 year postoperatively, patients were divided into progressors, regressors', and unchanged. We analyzed data on medical history, baseline body mass index, surgery type, and difference in body mass index after 1 year. RESULTS: Data on cIMT were available for 134 patients. Thirty-four patients (25.4%) had a cIMT regression with a mean decrease of .1 mm (-.24 to -.06), 10 patients (7.5%) were progressors with a mean increase of .1 mm (.07-.30), and 90 patients (67.2%) remained unchanged. Progressors more often had type 2 diabetes (P = .035) and hypertension (P = .020). Data on PWV were available for 120 patients, of whom 91 (75.8%) were regressors, 26 (21.6%) remained unchanged, and 3 (2.5%) were progressors. Predictors of PWV changes were total plasma cholesterol and hypertension at baseline. CONCLUSIONS: A significant improvement of the vascular quality already after 1 year of follow-up was established in 25%-76% of all patients after bariatric surgery and the vast majority showed stabilization.

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.

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.

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.

[A healthy young man with lost ribs]. / Een gezonde jongeman met verdwenen ribben.

A 19-year-old man received a routine medical exam, he had no medical history. A defect on the left thoracic wall was noted and an X-ray and CT-scan of the thorax showed osteolysis of the 3rd and 4th rib. Histopathology of surgical biopsies revealed non-malignant vascular proliferation consistent with Gorham's disease.

The interrelationship between preoperative anemia and N-terminal pro-B-type natriuretic peptide: the effect on predicting postoperative cardiac outcome in vascular surgery patients.

INTRODUCTION: N-terminal pro-B-type natriuretic peptide (NT-proBNP) predicts adverse cardiac outcome in patients undergoing vascular surgery. However, several conditions might influence this prognostic value, including anemia. In this study, we evaluated whether anemia confounds the prognostic value of NT-proBNP for predicting cardiac events in patients undergoing vascular surgery. METHODS: A detailed cardiac history, resting echocardiography, and hemoglobin and NT-proBNP levels were obtained in 666 patients before vascular surgery. Anemia was defined as serum hemoglobin <13 g/dL for men and <12 g/dL for women. Troponin T measurements and 12-lead electrocardiograms were performed on postoperative days 1, 3, 7, and 30 and whenever clinically indicated. The primary end point of the study was the composite of 30-day postoperative cardiovascular death, nonfatal myocardial infarction, and troponin T release. Receiver operating characteristic curve analysis was used to assess the optimal cutoff value of NT-proBNP for the prediction of the composite end point. Multivariable regression analysis was used to assess the additional value of NT-proBNP for the prediction of postoperative cardiac events in nonanemic and anemic patients. RESULTS: Anemia was present in 206 patients (31%) before surgery. Hemoglobin level was inversely related with the NT-proBNP levels (beta coefficient = -2.242; P = 0.025). The optimal predictive cutoff value of NT-proBNP for predicting the composite cardiovascular outcome was 350 pg/mL. After adjustment for clinical cardiac risk factors, both anemia (odds ratio [OR] 1.53; 95% confidence interval [CI]: 1.07-2.99) and increased levels of NT-proBNP (OR 4.09; 95% CI: 2.19-7.64) remained independent predictors for postoperative cardiac events. However, increased levels of NT-proBNP were not predictive for the risk of adverse cardiac events in the subgroup of anemic patients (OR 2.16; 95% CI: 0.90-5.21). CONCLUSIONS: Both anemia and NT-proBNP are independently associated with an increased risk for postoperative cardiac events in patients undergoing vascular surgery. NT-proBNP has less predictive value in anemic patients.