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.

The safety and efficiency of a fast-track protocol for sleeve gastrectomy: a team approach.

BACKGROUND: Increasing numbers of morbid obese patients has led to increased numbers of bariatric procedures. Fast-track protocols are being developed to enhance the available resources, while maintaining a safe procedure. Reported results on safety merely apply to a mixed bariatric population. The objective was to evaluate safety and efficiency of the fast-track principles in patients undergoing sleeve gastrectomy. METHODS: Retrospective observational study including patients undergoing primary sleeve gastrectomy at the Obesity Centre of the Catharina Hospital Eindhoven, the Netherlands. Conventional perioperative care (CC) (2008-2011) versus a fast-track protocol (FT) (2011-2013), using short-acting anesthetic agents, a multi-modal pain protocol to reduce opioids, and early mobilization. The main parameters for safety were intraoperative, early and late postoperative complications. Procedure time and hospital stay were used to evaluate efficiency. RESULTS: This study included 805 patients, 494 patients were subjected to the conventional care and 318 patients to fast-track protocol. A reduction of median operation time from 60 (CC) to 40 minutes (FT) (P<0.001) and a reduction in median length of hospital stay from three to two days (P=0.001), with a significant reduction in early postoperative complications (9.9% [CC] vs. 5% [FT], P=0.016) was achieved. The amount of late complications was comparable for both groups (5.1% [CC] vs. 4.4% [FT] [P=0.738]). CONCLUSIONS: Implementation of a fast-track protocol for sleeve gastrectomy is safe and efficient. It effectively reduces operation time and length of hospital stay, while improving postoperative outcome. This pleads for standard implementation of the fast-track protocol in sleeve gastrectomy.

Transection versus preservation of the neurovascular bundle of the lesser omentum in primary Roux-en-Y gastric bypass surgery.

BACKGROUND: A gastric pouch in Roux-en-Y gastric bypass (RYGB) surgery can be created after transection of the perigastric neurovascular bundle or by preserving these structures. Some surgeons choose to transect the neurovascular bundle (NBT), containing branches of the vagus nerve, because this might be related to additional weight loss, whereas others advocate preservation (NBP) to reduce postoperative complications. OBJECTIVES: This study assessed the effect of both techniques after primary RYGB. SETTING: All patients undergoing primary RYGB in a large bariatric center in the Netherlands between January 2010 and December 2013 were included. METHODS: Patient demographic characteristics, operative details, postoperative complications and weight loss after 1 year were retrospectively analyzed. RESULTS: A total of 773 consecutive patients were included (85.5% female). NBT was performed in 407 patients (52.7%), whereas NBP was performed in 366 patients. There were no missing data and 81.2% of patients completed the 1-year follow-up. Postoperative complications were found in 66 patients (8.5%). A total of 49 patients (6.3%) either had an anastomotic leakage, postoperative bleeding, or intraabdominal abscess (NBT 8.8% versus NBP 3.6%, P = .003). Percentage total weight loss (NBT 34.5%±6.9% versus NBP 33.4%±6.9%; P = .011) differed to a lesser extent between groups, although this was significant. Neurovascular bundle transection was identified as independent factor among others for occurrence of leakage, bleeding, and abscess development (OR 2.886; 95% CI [1.466-5.683]; P = .002). CONCLUSIONS: Transection of the neurovascular bundle in RYGB is associated with more complications. Furthermore, weight loss is not relevantly increased. Further research is necessitated to substantiate these findings.

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.

STOP-Bang and the effect on patient outcome and length of hospital stay when patients are not using continuous positive airway pressure.

BACKGROUND: In patients undergoing surgical interventions under general anesthesia, obstructive sleep apnea syndrome (OSA) can cause serious perioperative cardiovascular or respiratory complications leading to fatal consequences, even sudden death. In this study we test the hypothesis that morbidly obese patients diagnosed by a polysomnography test and using continuous positive airway pressure (CPAP) therapy have fewer and less severe perioperative complications and a shorter hospital stay than patients who have a medical history that meets at least three STOP-Bang criteria and are not using CPAP therapy. METHODS: Postoperative hospital stay and pulmonary complications were analyzed in three groups of morbidly obese patients undergoing bariatric surgery (Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy) between January 2009 and November 2013 (n = 693). Group A comprised 99 patients who were preoperatively diagnosed with OSA based on polysomnography results. These patients used CPAP therapy before and after surgery. Group B consisted of 182 patients who met at least three STOP-Bang criteria but who were not diagnosed with OSA based on polysomnography results. These patients did not use CPAP. Group C, the reference group, comprised 412 patients who scored one to two items on the STOP-Bang. RESULTS: During the perioperative period, Group B patients had a significantly (p < 0.001) higher cumulative rate of pulmonary complications, worse oxygen saturation, respiratory rates, and increased length of stay in hospital. There was also two cases of sudden death in this group. CONCLUSION: Based on these results, we conclude that patients meeting at least three STOP-BANG criteria have higher postoperative complications and an increased length of hospital stay than patients using CPAP.

Bariatric surgery with operating room teams that stayed fixed during the day: a multicenter study analyzing the effects on patient outcomes, teamwork and safety climate, and procedure duration.

BACKGROUND: Bariatric surgery durations vary considerably because of differences in surgical procedures and patient factors. We studied the effects on patient outcomes, teamwork and safety climate, and procedure durations resulting from working with operating room (OR) teams that remain fixed for the day instead of OR teams that vary during the day. METHODS: Data were collected in 2 general teaching hospitals, consisting of patientrelated demographic and intraoperative data and of staffrelated survey data on team work and safety climate. The procedure durations of fixed and conventional OR teams were analyzed by comparison of means tests and by regression methods to control for the effects of surgeon, surgical experience, and procedure type. RESULTS: For both hospitals, we obtained the following 4 results for working on bariatric procedures with OR teams that remained fixed for the day. First, patient outcomes did not worsen. Second, teamwork and safety climate (both measured on a 5-point scale) improved significantly, for teamwork + 0.86 (95% confidence interval [CI], 0.54 to 1.18) and for safety climate + 0.75 (95% CI, 0.40 to 1.11). Third, the procedures were performed significantly faster, as both the mean and the SD of procedure durations decreased. After correcting for learning effects, the average reduction of durations was 10.8% (99% CI, 5.0% to 15.3%, or 4 to 13 minutes). This gain was mainly realized for surgical time (12%; 99% CI, 5% to 18%, or 3 to 11 minutes). The effect on peripheral time, defined as procedure time minus surgical time, is not significant (3%; 99% CI, -6% to 12%, or -1 to 3 minutes). Fourth, additional gains were obtained by performing the same type of procedure multiple times within the same day (5% per every next procedure of the same type; 99% CI, 3% to 7%, or 3 to 6 minutes). CONCLUSIONS: Working with fixed teams in bariatric surgery reduced procedure durations and improved teamwork and safety climate, without adverse effects on patient outcomes.

Characteristics and outcome of patients admitted to the ICU following bariatric surgery.

BACKGROUND: This study evaluates the characteristics and outcome of patients admitted to the ICU following bariatric surgery. METHODS: Descriptive study. A review of a prospectively collected database of our bariatric surgery procedures from 2003 until 2006 was performed. The study was performed in a tertiary level, mixed medical and surgical, adult ICU of a large referral hospital. RESULTS: Of the 265 patients undergoing bariatric surgery (mainly gastroplasties and Roux-en-Y gastric bypasses), 22 (8%) were admitted to the ICU, of which 14 (64%) were on an elective basis and eight (36%) emergently. Hospital length of stay (LOS) for all patients was 4.5 days and ICU LOS was 12 days. Most elective admissions were standard procedure because of obstructive sleep apnea (OSA) or super obesity, with a median ICU stay of 1 day. Emergent admissions were mainly done after emergent surgery due to surgical complications and had a median ICU stay of 8 days. Only two patients needed intensive care for more than 3 days. There were no deaths during ICU stay. CONCLUSIONS: The ICU admission rate in our report is 8%. This study showed that 32 ICU days are needed per 100 diverse bariatric procedures. Most patients are admitted to the ICU for only a few days and the majority of the admissions is planned.

Bariatric surgery and bariatric psychology: general overview and the Dutch approach.

BACKGROUND: Obesity is a chronic, multifactorially caused disease with serious somatic and psychosocial comorbidity as well as economical consequences. In the Netherlands, between 1993 and 1997, the prevalence of morbid obesity was 0.2% for men and 0.6% for women. Although bariatric surgery generally is an effective intervention, it does not lead to equal results in every patient. The long-term efficacy is predominantly determined by compliance to adequate dietary rules in which psychosocial factors can play a major role. METHODS: Questionnaires were sent to the surgery departments of all hospitals in the Netherlands. Subsequently, a second questionnaire was sent to clinical psychology departments of hospitals which perform bariatric surgery. RESULTS: In 28 Dutch hospitals (19%), bariatric surgery is being performed, mostly using restrictive procedures. Almost all hospitals have a multidisciplinary selection-process, and all surgeons and psychologists use multiple selection-criteria. Regarding these criteria, there is more consensus between surgeons than between psychologists. In most hospitals, patients are psychologically assessed prior to surgery. However, postoperative assessment is relatively rare, as is preoperative and postoperative psychological treatment. CONCLUSION: In the Netherlands, bariatric surgery is still relatively uncommon and mostly limited to restrictive procedures. Irrespective of BMI and eating behavior, the majority of patients will be offered a restrictive procedure. The involvement by the psychological and/or psychiatric discipline is not optimal yet; especially, postoperative assessment and pre- and postoperative treatment are not frequently performed, in spite of the fact that these programs can enhance the success rate of bariatric surgery.