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PURPOSE: Obstructive sleep apnea (OSA) is highly prevalent but mostly undiagnosed in obese patients scheduled for bariatric surgery. To prevent cardiopulmonary complications, many clinics perform preoperative OSA screening. Consequently, adequate adherence to continuous positive airway pressure (CPAP) therapy is essential but challenging. We aimed to evaluate CPAP adherence and its influence on postoperative outcomes.METHODS: In a prospective multicenter cohort study, we compared different perioperative strategies for handling undiagnosed OSA in bariatric patients. In this subgroup analysis, patients newly diagnosed with OSA were compared to those with pre-existing OSA. We assessed inadequate CPAP adherence, defined as RESULTS: In total, 272 patients with newly diagnosed OSA (67.4%) and 132 patients with pre-existing OSA (32.6%) were included. Before surgery, 41 newly diagnosed patients used CPAP inadequately, compared to 5 patients with pre-existing OSA (15% vs. 4%, p = 0.049). Six months after surgery, inadequate CPAP use increased to 73% for newly diagnosed patients and 39% for patients with pre-existing OSA, respectively (p CONCLUSION: Inadequate CPAP adherence is higher in bariatric patients newly diagnosed with OSA when compared to patients with pre-existing OSA. Strategies to increase CPAP adherence may be valuable when considering routine OSA screening and CPAP therapy in patients undergoing bariatric surgery. Further studies are needed to improve current guidelines on perioperative OSA management of obese patients.TRIAL REGISTRATION: POPCORN study, registered at Netherlands Trial Register, https://www.trialregister.nl/trial/6805 . ID no: 6805.

Background: Protein intake and physical activity have a substantial impact on body composition and weight loss outcomes after bariatric surgery. The 24-h dietary recall and 6-min walk test (6mWT) are frequently used to monitor protein intake and physical activity, respectively. Despite its frequent use, it is unknown whether these tests can predict long-term weight loss. Methods: This retrospective study included 85 patients who underwent laparoscopic Roux-en-Y gastric bypass. Protein intake was recorded using the 24-h dietary recall and physical function was measured using the 6mWT. Data about total weight loss (TWL) and nonresponse (i.e., insufficient weight loss and weight regain) were collected up to 5 years. Multiple regression analyses were performed to examine the predictive value of the 24-h dietary recall and 6mWT on weight loss outcomes. Results: The mean protein intake 1 year postoperatively was 68.1 +/- 15.0 g/day and the mean distance covered during the 6mWT was 591.7 +/- 67.9 m. Both the 24-h dietary recall and 6mWT were not significantly associated with TWL and neither with nonresponse. Conclusions: The 24-h dietary recall and 6mWT are poor predictors for long-term weight loss outcomes after gastric bypass. Despite the well-known advantages of these clinical tests, other monitoring tests are suggested for future research.

Background Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. Methods This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. Discussion The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. Trial registration ClinicalTrials.gov identifier: NCT04101773

Background Weight loss outcomes after bariatric surgery are less favorable in super morbidly obese patients (BMI ≥50 kg/m2). Non-response, either defined as insufficient weight loss or weight regain after initial successful weight loss, is a matter of serious concern in these patients. The primary banded Roux-en-Y gastric bypass has shown promising results regarding weight loss in the bariatric population. However, up to now, long-term comparative data about the banded and non-banded bypass in superobese patients is lacking. The aim of this study is to assess the added value of the banded Roux-en-Y gastric bypass in superobese patients on long-term weight loss outcomes. Methods This single center study will evaluate superobese patients who receive a non-banded Roux-en-Y gastric bypass (NB-RYGB) and a banded Roux-en-Y gastric bypass (B-RYGB). Data from the NB-RYGB group will be collected in retrospect, while data from the B-RYGB group will be collected prospectively. When performing a B-RYGB, a 7.0–8.0 cm silastic ring (MiniMizer®) will be placed proximal to the gastrojejunostomy. The main outcomes of this study are weight loss and non-response during a 10 year follow-up period. Secondary outcomes are reduction of obesity related comorbidities and medication, (ring-related) morbidity and mortality, complications, re-operations, patient satisfaction and health-related quality of life. A total of 142 patients will be included in this study. Discussion This study will help establish the clinical utility of the B-RYGB in superobese patients. Trial register NL8093. Registered 15 October 2019 - Retrospectively registered on the Dutch Registry of Clinical trials, www.trialregister.nl

Studies suggest that postoperative complications are a risk factor for venous thromboembolism (VTE) after bariatric surgery. Knowledge of factors associated with a higher risk of VTE after bariatric surgery may be essential to select patients who may benefit from either prolonged or intensified thrombosis prophylaxis. The aim of this study is to determine the relationship between postoperative complications and VTE after bariatric surgery and other classical risk factors. A retrospective multicenter case-control study was performed in patients who had bariatric surgery between January 2008 and September 2011. VTE until 6 months after surgery was registered, and patients were contacted to ascertain the results. For every case of VTE after surgery, 6 control patients were selected who were matched for gender, age, participating center and type of surgery. Risk factors for VTE before and after surgery and postoperative complications were registered. A total of 2,064 surgeries were included. In 12 patients, VTE occurred within 6 months after bariatric surgery (incidence 0.58 %, 95 % confidence interval (CI) = 0.25–0.93). There was a strong association of complications after surgery (cases 91.7 %, controls 15.3 %, odds ratio (OR) 61.0; 95 % CI = 7.1–521.3) or intensive care admission (cases 50.0 %, controls 11.1 %, OR = 8.0; 95 % CI = 2.1–30.8) with VTE. The majority of postoperative complications were anastomotic leak, abdominal abscess, and infection. We could not detect an association between classical thrombosis risk factors and postoperative VTE. The incidence of VTE is low after bariatric surgery using thrombosis prophylaxis. However, there is a strong association between postoperative complications and VTE. These patients may benefit from more intensive thrombosis prophylaxis.

Several studies conducted in the USA have demonstrated that the effectiveness of bariatric surgery differs between patients from African and European origin. However, little is known on differences in outcomes after bariatric surgery between individuals from other ethnic backgrounds. In this retrospective study, we found that, in terms of weight loss, gastric bypass surgery is less effective in African, South Asian, Turkish and Moroccan patients than in their ethnic Dutch counterparts. Our results underscore that ethnic differences in the effectiveness of bariatric surgery are not limited to those between patients of African and European origin, but extend to other minority groups as well. Therefore, it is important that prospective studies both determine ethnic differences in weight loss-related improvement of co-morbidities and elucidate the exact reasons for these ethnic disparities.

PURPOSE: Fistulotomy is considered to be the golden standard for the treatment of low perianal fistula but might have more influence on continence status than believed. This study was performed to evaluate the healing rate after a fistulotomy and to show results for continence status. METHODS: A retrospective database study was performed in one university medical center and its six affiliated hospitals. All patients treated with a fistulotomy for a low perianal fistula were identified. Healing and recurrence of the fistula were identified. Questionnaires on continence status and quality of life were mailed to all patients. RESULTS: In total, 537 patients were identified. The primary etiology of the fistulas was cryptoglandular (66.5%). Recurrence was seen in 88 patients (16.4%) resulting in a primary healing rate of 83.6%. After secondary treatment for the recurrence, another 40 patients healed. This resulted in a secondary healing rate of 90.3%. The Kaplan-Meier analysis showed that at 5 years, the healing rate was 0.81 (95% confidence interval (95% CI) 0.71-0.85). The mean Vaizey score was 4.67 (SD 4.80). Major incontinence, defined as a Vaizey score of >6, was seen in 95 (28.0%) patients. Only 26.3% of the patients had a perfect continence status (Vaizey score 0). Quality of life was not different from the general population. CONCLUSIONS: Fistulotomy seems to be associated with a healing rate of 0.81 (95% CI 0.71-0.85) after 5 years. However, major incontinence is still reported by 26.8% of patients and only 26.3% of patients had a perfect continence status.

OBJECTIVE: This study investigates whether fasting plasma glucose (FPG) levels in obese subjects are associated with the number of preadipocytes and their adipokine-secretion capabilities. DESIGN: Abdominal subcutaneous and omental adipose tissues were obtained from 10 female and four male obese subjects (age 37 +/- 8 years; BMI 48 +/- 13 kgm(2)) with a wide range of FPG (range: 4.3-10.6 mm). Stromal vascular cells (SVC) were isolated and cultured and the number of attached SVC (aSVC) per gram adipose tissue determined. The aSVCs were differentiated in vitro to become adipocytes, and the secretion of the adipokine leptin and adiponectin in the culture media was determined. Spearman rank correlation coefficients were calculated between FPG and preadipocyte number and adipokine secretion. PATIENTS: Subject-inclusion criteria: BMI >40 kg/m(2) and for severe comorbid conditions BMI >35 kg/m(2). Subject-exclusion criteria: severe cardiopulmonary pathology (ASA class 3), history of bariatric surgery, manifest psychopathology, 18 years < age > 60 years and for upper-abdominal surgery, age >50 years. All females in the study had regular menstrual periods. None of participants received glucose-lowering medication. RESULTS: No association was observed between BMI and fasting glucose levels. More than 90 +/- 20% of the cultured aSVC fraction was able to store fat droplets, indicating the presence of preadipocytes. A strong negative association was observed between omental preadipocyte number and FPG. A strong association was observed between adipokine secretion by the omental preadipocytes and FPG. No association was observed between subcutaneous preadipocyte number and adipokine secretion and FPG. CONCLUSIONS: In morbid obese subjects, low number of omental preadipocytes with high-leptin- and low-adiponectin-secretion profiles is associated with high FPG.

Background: Laparoscopic adjustable gastric banding (LAGB) and open vertical banded gastroplasty (VBG) are treatment modalities for morbid obesity. However, few prospective randomized clinical trials (RCT) have been performed to compare both operations. Methods: 100 patients (50 per group) were included in the study. Postoperative outcomes included hospital length of stay (LOS), complications, percent excess weight loss (%EWL), BMI and reduction in total comorbidities. Follow-up in all patients was 2 years. Results: LOS was significantly shorter in the LAGB group. 3 LAGB were converted to open (1 to gastric bypass). Directly after VBG, 3 patients needed relaparotomies due to leakage, of which one (2%) died. After 2 years, 100% follow-up was achieved. BMI and %EWL were significantly decreased in both groups but significantly more in the VBG group compared to the LAGB group (31.0 kg/m2 and 70.1% vs 34.6 and 54.9% respectively). Co-morbidities significantly decreased in both groups in time. 2 years after LAGB, 20 patients needed reoperation for pouch dilation/slippage (n=12), band leakage (n=2), band erosion (n=2) and access-port problems (n=4). In the VBG group, 18 patients needed revisional surgery due to staple-line disruption (n=15), narrow outlet (n=2) or insufficient weight loss (n=1). Furthermore, 8 VBG patients developed an incisional hernia. Conclusion: This RCT demonstrates that, despite the initial better weight loss in the VBG group, based on complication rates and clinical outcome, LAGB is preferred. It had a shorter LOS and less postoperative morbidity.

Gastric myoelectrical activity in morbidly obese patients before and 3 months after gastric restrictive surgery.van Dielen FM, de Cock AF, Daams F, Brummer RJ, Greve JW.Department of General Surgery, University Hospital, Maastricht, The Netherlands. f.vandielen@ah.unimaas.nlBACKGROUND: Morbid obesity is often associated with gastrointestinal motor disorders. The aim of this study was to investigate gastric motility in morbid obesity, using electrogastrography (EGG) before and 3 months after gastric restrictive surgery. METHODS: 40 morbidly obese subjects (age 40.6+/-10.3 years, BMI 46.4+/-5.7 kg/m2) were studied. VBG and Lap-Band operations were performed in 19 and 21 patients respectively. The following EGG-parameters were determined, both during fasting (f) and postprandially (pp): dominant frequency (DF(f/pp)), dominant power (DP(f/pp)), dominant frequency and power instability coefficient (DFIC and DPIC respectively) and power ratio. RESULTS: In the Lap-Band group, DF(pp), DP(pp) and DFIC(pp) were significantly higher compared with the preprandial state, both preoperatively and 3 months postoperatively. After VBG, DF(f) and DFIC(pp) were significantly lower and DPIC(f) significantly higher compared with the preoperative state. Furthermore, DF(pp) and DP(pp) were significantly higher than the preprandial values. However, in both types of operations, power ratio did not differ significantly between the preoperative and postoperative situation. Furthermore, no clear difference in EGG-parameters between both operations could be observed. CONCLUSION: After gastric restrictive surgery, no major changes in gastric myoelectrical activity occurred, suggesting that if clinical motility problems occur after bariatric surgery, they are not due to gastric myoelectrical dysfunction

The effect of pegylated recombinant human leptin (PEG-OB) on weight loss and inflammatory status in obese subjects.Hukshorn CJ, van Dielen FM, Buurman WA, Westerterp-Plantenga MS, Campfield LA, Saris WH.Nutrition and Toxicology Research Institute Maastricht, Department of Human Biology, Maastricht University, The Netherlands. c.hukshorn@hb.unimaas.nlOBJECTIVE: To investigate whether weekly subcutaneous administration of 60 mg of long-acting pegylated human leptin (PEG-OB) for 8 weeks was able to influence weight loss, metabolic profile and inflammatory status of obese subjects on a mildly hypoenergetic diet (deficit: 3.2 MJ/day). DESIGN: A prospective, randomized, double-blind and placebo-controlled single-center trial. SUBJECTS: Twenty-eight healthy, obese subjects (16 women, 12 men; age 22-65 y; body mass index 27.7-38.7 kg/m2). MEASUREMENTS: Bodyweight, metabolic profile (including lipids), C-reactive protein (CRP) and soluble TNF alpha-receptor (sTNF-R) 55 and 75 levels. RESULTS: At the end of the study no significant differences in the delta or percentage weight loss between the placebo (n = 14) and PEG-OB (n = 14) groups was observed. Also the changes in metabolic profile, CRP, sTNF-R55 and R75 concentrations between the two groups after 8 weeks of treatment did not differ. CONCLUSION: Weekly injection of 60 mg PEG-OB did not lead to additional weight loss after 8 weeks of treatment. Furthermore, PEG-OB administration did not affect the changes in metabolic profile and the inflammatory status of obese subjects.

Objective: Insulin seems to have vasodilator properties, but it is unclear if insulin in postprandial concentrations is a specific vasodilator of skeletal muscle resistance arterioles only or that various types of vessels are affected. The aim of the present study was to determine the direct effects and the time course of regional/local physiological hyperinsulinemia on skeletal muscle arterioles, skin blood flow and peripheral venous tone and the reponsiveness of these different vascular beds to noradrenaline. Methods: In protocol 1 ( n =12) we infused insulin into the brachial artery for 180 min (3.5 mU/min) and evaluated the effects on forearm (muscle) blood flow (FBF) and skin blood flow (SBF). Furthermore, noradrenaline (0.025, 0.01 and 0.4 μg/min) was infused (i.a.) at baseline, at 90 and 180 min after the start of insulin. In protocol 2 ( n =10) the same regional forearm hyperinsulinemia was achieved, but now the local venous responsiveness to noradrenaline (1.7–55 ng/min, at baseline and at 90 and 180 min) was measured in a dorsal hand vein. In protocol 3 we evaluated the local effects of different doses of insulin (1–100 mU/min) infused directly into hand veins preconstricted with phenylephrine. Results: Forearm hyperinsulinemia (≈50 mU/l) led to a significant increase in FBF after 180 min (median 26%, interq. ranges 5–50, P

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a safe technique with few direct postoperative complications. However, long-term complications such as slippage and pouch dilatation are a well-known problem and re-operations are necessary in a substantial number of patients. In this study, the results of laparoscopic re-operations after LAGB are evaluated. METHODS: 33 patients had a re-operation because of failed LAGB. 29 patients had major re-operation and 4 patients minor re-operation under local anesthesia. The charts of these patients were retrospectively studied. RESULTS: Mean time between the first band placement and re-operation was 28.1 +/- 17.6 months. The cause of band dysfunction was anterior slippage (n=17), band erosion (n=5), band intolerance (n=3), posterior slippage (n=2) and band leakage (n=2). Symptoms of band dysfunction were vomiting (n=16), pyrosis (n=13), nausea (n=8), retrosternal pain (n=11) and regurgitation (n=5). Laparoscopic refixation of the band was performed in 19 patients: the band was replaced in 4 patients while in 1 patient the band was removed; in 3 patients, the laparoscopic procedure was converted to open surgery; 5 patients underwent conversion to a bypass procedure (biliopancreatic diversion in 3 and gastric bypass in 2). There were no direct postoperative complications except for wound infections (n=2). Postoperative follow-up was 100% with a mean period of 34 +/- 19 months. BMI decreased further from 37.5 +/- 6.4 kg/m(2) before re-operation to 33 +/- 7 kg/m(2). Obesity-related co-morbidity also decreased further or completely dissolved. 3 patients (9%) again developed anterior slippage and a second laparoscopic re-operation was necessary. CONCLUSIONS: A laparoscopic re-operation for band-related complications after LAGB is safe and feasible. With band slippage, a laparoscopic refixation was possible in 89%. Re-operation leads to further decrease in BMI and obesity-related co-morbidities.

Obesity is demonstrated to be associated with an enhanced inflammatory state, which is suggested to be a cause for the development of obesity-related morbidity. It was hypothesized that a decrease in body weight in morbid obese subjects would lead to a reduction of the inflammatory state in these subjects. Weight loss was achieved by gastric restrictive surgery in 27 morbidly obese patients. Preoperative as well as 3-, 6-, 12-, and 24-month postoperative plasma concentrations of inflammatory mediators macrophage inhibitory factor, plasminogen activator inhibitor-1, lipopolysaccharide binding protein, alpha-1 acid glycoprotein, C-reactive protein, soluble TNFalpha receptors 55 and 75, and leptin were measured. Macrophage inhibitory factor levels remained low normal for 6 months, during weight loss, after which they significantly increased to normal levels at 24 months postoperatively. The other inflammatory mediators remained elevated up to minimally 3 months postoperatively; thereafter they decreased significantly. Both TNFalpha receptors remained elevated up to at least 12 months postoperatively to decrease significantly at 2 yr postoperatively. This study demonstrates that during weight loss, after gastric restrictive surgery, inflammatory mediators remain elevated for at least 3 months postoperatively, suggesting initially an ongoing inflammatory state. However, 2 yr after surgery, the inflammatory mediators reach near normal values.These findings may be an explanation for the reduced comorbidity seen in morbidly obese patients after gastric restrictive surgery.

Decreased plasma orexin-A levels in obese individuals.Adam JA, Menheere PP, van Dielen FM, Soeters PB, Buurman WA, Greve JW.Nutrition and Toxicology Institute Maastricht (NUTRIM), Department of General Surgery, Maastricht University, Maastricht, The Netherlands.Orexin-A and -B stimulate appetite and food intake in rats. Orexins and orexin receptors are present in the hypothalamus as well as the enteric nervous system, the pancreas and the gut. The presence of orexins in peripheral blood, however, has not yet been reported. To determine whether orexin-A is present in human plasma and is related to body weight, we measured plasma orexin-A and leptin levels in a population with a body mass index (BMI) range from 19.8 to 59 kg/m(2). Plasma orexin-A levels correlated negatively and plasma leptin levels correlated positively with BMI. In obese and morbidly obese individuals, orexin-A levels were significantly lower and leptin levels were significantly higher when compared to normal. Our results support previous data suggesting that orexin-A acts also in a peripheral manner. The fact that lower levels of plasma orexin-A are present in obese individuals suggests that it is involved in the regulation of human energy metabolism

Increased leptin concentrations correlate with increased concentrations of inflammatory markers in morbidly obese individuals.van Dielen FM, van't Veer C, Schols AM, Soeters PB, Buurman WA, Greve JW.Department of General Surgery, University Hospital, Maastricht, The Netherlands.OBJECTIVE: To study whether an increase of plasma leptin concentrations, as observed in the case of increased body weight, is associated with an inflammatory state. SUBJECTS: Sixty-three healthy subjects with body mass index (BMI) ranging from 20 to 61 kg/m2. MEASUREMENTS: Plasma concentrations of leptin, the inflammatory parameter soluble TNF-alpha receptors (TNFR55 and TNFR75), the acute phase proteins lipopolysaccharide binding protein (LBP), serum amyloid A (SAA), alpha-acid glycoprotein (AGP), C-reactive protein (CRP), plasminogen activator inhibitor-1 (PAI-1) and the anti-inflammatory soluble Interleukin-1 decoy receptor (sIL-1RII) were measured. RESULTS: As expected, BMI correlated significantly with leptin (r=0.823, P