Bart A. van Wagensveld

The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitisA and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitisB in perforated diverticulitis (NTR2037)

BackgroundRecently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis).Methods/DesignIn this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmanns procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmanns procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs.DiscussionThe Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis.Trial registrationNederlands Trial Register NTR2037

Calorie Restriction is a Major Determinant of the Short‐Term Metabolic Effects of Gastric Bypass Surgery in Obese Type 2 Diabetic Patients

Roux‐en‐Y gastric bypass (RYGB) and restrictive weight loss interventions, such as gastric banding (GB) and very‐low‐calorie diets (VLCD) directly impact glucose metabolism, possibly by calorie restriction and/or altered secretion of gut hormones. We aimed to establish the direct endocrine and metabolic effects of RYGB compared to restrictive interventions in obese glucose‐tolerant (NGT) subjects and subjects with type 2 diabetes (T2DM).

Is esophagogastroduodenoscopy before Roux-en-Y gastric bypass or sleeve gastrectomy mandatory?

BACKGROUND Roux-Y Gastric Bypass is a frequently used technique in bariatric surgery. Postoperative anatomy is altered by exclusion of the stomach, which makes this organ inaccessible for future esophagogastroduodenoscopy (EGD). The value of preoperative assessment of the stomach is unclear. Some institutions choose to investigate the future remnant stomach by EGD, others do not. Aim of the present study is to quantify the yield of preoperative EGD in our institution. METHODS Patients, planned for primary laparoscopic Roux-Y Gastric Bypass (LRYGB) or laparoscopic sleeve gastrectomy from December 2007 until August 2012, were screened by EGD in advance. Results of EGD and patient characteristics were retrospectively analyzed and categorized according to a classification system based on intervention needed. RESULTS 523 patients (122 male, 401 female, mean age 44.3 years, average BMI 46.6) underwent preoperative EGD. In 257 patients (48.9%) no abnormality was found (group A), 117 patients (17.2%) had abnormalities without treatment consequences (B1), 84 patients (of the 326 tested [comment #1, reviewer #1, 26.8%] were H. Pylori positive (B2), in 75 (14.3%) treatment with proton pump inhibitors was required (B3), 6 (1.1%) required follow up EGD before surgery (C). For1 patient (0.2%) the operation was canceled because preoperative EGD presented with Barretts esophagus with carcinoma (D). When all abnormalities were taken into account, baselines did show a significant difference for age, gender and reflux symptoms. CONCLUSION Standard preoperative assessment by EGD in patients who are planned for bariatric surgery is not indicated. The number needed to screen to find clinically significant abnormalities is high.

Calorie restriction and Roux-en-Y gastric bypass have opposing effects on circulating FGF21 in morbidly obese subjects.

To study the effect of different weight loss strategies on levels of the metabolic regulator FGF21 in morbidly obese females with normal glucose tolerance (NGT) or type 2 diabetes mellitus (T2DM).

Autonomic nervous system activity in diabetic and healthy obese female subjects and the effect of distinct weight loss strategies

OBJECTIVE Obesity and type 2 diabetes mellitus (T2DM) are reported to be associated with relative overactivity of the sympathetic nervous system (SNS), which is reversible by weight loss. However, direct effects of weight loss by calorie restriction vs Roux-en-Y gastric bypass (RYGB) on SNS overactivity were not studied in parallel. This study compared the effects of RYGB vs restrictive weight loss in obese patients with normal glucose tolerance (NGT) and with T2DM on SNS function as measured by heart rate variability (HRV). DESIGN AND METHODS Lean (n=12), obese NGT (n=27) and T2DM (n=27) subjects were included in this study. Weight reduction in NGT subjects was achieved by gastric banding (GB) or RYGB and in T2DM subjects by RYGB or high-protein very-low-calorie diet (VLCD). HRV analysis was performed and blood samples were taken at baseline, 3 weeks and 3 months after intervention. RESULTS At baseline, T2DM subjects showed SNS overactivity and NGT subjects showed similar, but non-significant, findings when compared with lean controls. Weight loss after 3 weeks was comparable in all treatment groups, whereas after 3 months, weight loss was most in VLCD and RYGB subjects. RYGB and VLCD treatment reduced SNS activity within 3 weeks in T2DM patients. After 3 months, restoration to normal autonomic nervous system activity was evident for all groups, except for the NGT-GB group. CONCLUSION We can conclude that SNS overactivity is more pronounced in obese T2DM subjects when compared with NGT subjects. Reduction of SNS overactivity coincides with weight loss with the time-course of reduction dependent on the type of intervention. Surgery or caloric restriction may transiently induce SNS overactivity but do not prevent a direct restoration of sympathovagal balance.

Roux-en-Y gastric bypass and calorie restriction induce comparable time-dependent effects on thyroid hormone function tests in obese female subjects

OBJECTIVE Obesity and weight loss influence thyroid hormone physiology. The effects of weight loss by calorie restriction vs Roux-en-Y gastric bypass (RYGB) in obese subjects have not been studied in parallel. We hypothesized that differences in transient systemic inflammation and catabolic state between the intervention types could lead to differential effects on thyroid hormone physiology. DESIGN AND METHODS We recruited 12 lean and 27 obese females with normal fasting glucose (normal glucose tolerant (NGT)) and 27 obese females with type 2 diabetes mellitus (T2DM) for this study. Weight loss was achieved by restrictive treatment (gastric banding or high-protein-low-calorie diet) or by RYGB. Fasting serum leptin, TSH, triiodothyronine (T₃), reverse T₃ (rT₃), and free thyroxine (fT₄) concentrations were measured at baseline and 3 weeks and 3 months after the start of the interventions. RESULTS Obesity was associated with higher TSH, T₃, and rT₃ levels and normal fT₄ levels in all the subjects when compared with the controls. After 3 weeks, calorie restriction and RYGB induced a decline in TSH levels and a rise in rT₃ and fT₄ levels. The increase in rT₃ levels correlated with serum interleukin 8 (IL8) and IL6 levels. After 3 months, fT₄ and rT₃ levels returned to baseline levels, whereas TSH and T₃ levels were persistently decreased when compared with baseline levels. No differences in the effects on thyroid hormone parameters between the interventions or between NGT and T2DM subjects were observed at any time point. CONCLUSIONS In summary, weight loss directly influences thyroid hormone regulation, independently of the weight loss strategy used. The effects may be explained by a combination of decreased leptin levels and transient changes in peripheral thyroid hormone metabolism.

The influence of prophylactic proton pump inhibitor treatment on the development of symptomatic marginal ulceration in Roux-en-Y gastric bypass patients: a historic cohort study.

BACKGROUND Marginal ulceration at the gastrojejunostomy is a serious complication after laparoscopic Roux-en-Y gastric bypass surgery (LRYGB) and occurs in 1%-16% of patients. Proton pump inhibitors (PPIs) might lower the occurrence of these ulcers. OBJECTIVES The aim of the present study was to evaluate the effect of 6 months prophylactic usage of PPIs on the development of marginal ulceration and compare this with a historic patient control group. SETTING A single institution cohort at a bariatric center of excellence, The Sint Lucas Andreas Zienkenhuis, Amsterdam METHODS A consecutive database of patients who underwent LRYGB from November 2007 to September 2012 in a single institution was retrospectively reviewed. From August 2011, patients received a standard dose of pantozol 40 mg once daily directly postoperatively for 6 months. No standard PPI prophylaxis was administered before August 2011, and the patients not using PPIs in this historic cohort served as the control group. RESULTS A total of 610 patients underwent LRYGB, of which 128 patients (21.0%) underwent revisional surgery. Postoperative PPIs were administered in the intervention group of 337 patients, compared with the historic control group consisting of 273 patients. Six patients (1.2%) who received postoperative PPIs versus 20 patients (7.3 %) in the historic control group developed marginal ulceration (P = .001). Patients using proton pump inhibitors developed fewer gastrointestinal complaints postoperatively (P< .001). CONCLUSIONS Routine usage of PPIs reduced the occurrence of marginal ulceration after LRYGB.

Evaluation of the obesity surgery mortality risk score for the prediction of postoperative complications after primary and revisional laparoscopic Roux-en-Y gastric bypass.

BACKGROUND The Obesity Surgery Mortality Risk Score (OS-MRS) is a validated instrument for mortality risk prediction in patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures classifying patients into low risk (class A), intermediate risk (class B), and high risk (class C). OBJECTIVES The primary aim of this study was to evaluate the accuracy of the OS-MRS in predicting postoperative complications after LRYGB. Secondarily, the postoperative complication rate between primary and revisional LRYGB was systematically analyzed. SETTING The Obesity Center Amsterdam, located in a large teaching hospital, in Amsterdam, The Netherlands. METHODS The OS-MRS was applied to a consecutive database of patients who underwent LRYGB from November 2007 onwards. Postoperative complications were scored according to the Clavien-Dindo classification. Revisional LRYGB was separately analyzed. RESULTS LRYGB was performed in 1667 patients either as a primary (81.5%) or revisional (18.5%) procedure. The majority (n = 1371, 82.2%) were female, mean age 44.6 (standard deviation 14.4) years and mean body mass index 44.2 (6.5) kg/m2. Nine hundred and four (54.2%) were OS-MRS class A, 642 class B (38.5%), and 121 (7.3%) class C. Complications occurred in 143 (10.5%) and 44 (14.2%) patients after primary and revisional surgery, respectively. In both primary and revisional LRYGB, there was no association between complications and the OS-MRS classification. Subanalysis comparing primary with revisional LRYGB found a significant association between revisional surgery and the development of severe complications (Clavien-Dindo≥3) (P = .003) and mortality (P = .017). CONCLUSION The OS-MRS was not an accurate predictor for postoperative complications in patients who underwent primary or revisional LRYGB. As in other studies, revisional surgery is an independent risk factor for the development of severe complications.

Persistent moderate or severe obstructive sleep apnea after laparoscopic Roux-en-Y gastric bypass: which patients?

BACKGROUND Patients with severe obesity and obstructive sleep apnea (OSA) might decide to undergo bariatric surgery to improve this disease or, more specifically, to become independent of continuous positive airway pressure (CPAP) therapy, which is generally indicated in case of moderate and severe OSA. Knowledge of this topic is important for patient education on expectations of surgical outcome. OBJECTIVES To evaluate the prevalence and phenotypes of patients with persistent moderate to severe OSA after bariatric surgery. SETTING Obesity Center Amsterdam, Amsterdam, the Netherlands. METHODS Patients who underwent a laparoscopic Roux-en-Y gastric bypass, had a preoperative apnea-hypopnea index (AHI)≥15/hr, and of whom a follow-up AHI/hr was available were included. RESULTS Out of 437 patients, 205 underwent pre- and postoperative polysomnography; 232 (53.1%) were lost to follow-up. Median AHI was 32.3/hr (range, 15-138) and mean body mass index was 46 (standard deviation 7.2) kg/m2. A postoperative AHI<15/hr was achieved in 152 patients (74.1%), whereas 53 (25.9%) still had moderate or severe disease 8.6 (standard deviation 4.8) months postoperatively. Predictive factors for persistent moderate to severe disease were age≥50 years, preoperative AHI≥30/hr, excess weight loss (EWL)<60%, and hypertension (area under the curve: .772). CONCLUSION After bariatric surgery, around three quarters of the moderate to severe OSA patients had no or mild OSA, whereas one quarter (25.9%) still had moderate to severe OSA. Age≥50 years, preoperative AHI≥30/hr, EWL<60%, and hypertension were predictive factors for this persistent postoperative AHI≥15/hr.

Obstructive sleep apnea and bariatric surgical guidelines: summary and update

Purpose of reviewIncreasing numbers of bariatric surgical procedures and the high prevalence of obstructive sleep apnea (OSA) in this population have resulted in a growing interest in the perioperative management of OSA in bariatric surgery. This review provides a summary of the first consensus guid