Effect of the EndoBarrier Device: a 4-Year Follow-up of a Multicenter Randomized Clinical Trial.

OBJECTIVE: To evaluate the long-term effect of the duodenal-jejunal bypass liner (DJBL) on weight loss and glycemic control. BACKGROUND: Data on the long-term effect of DJBL treatment is still missing. METHODS: From 2010 to 2012, 29 patients were treated with the DJBL at center A and center B, as part of a multicenter randomized controlled trial. Prior to implantation and after removal of the DJBL, all patients underwent standardized physical examination and blood sampling. Four years after removal of the DJBL, included patients underwent standardized physical examination and blood sampling as previously performed during the initial study. RESULTS: Out of the 29 patients, 15 patients were eligible for follow-up with a median duration of 42 months. Five patients had successfully received additional bariatric surgery. Four years after explantation of the DJBL, median weight in these 15 patients was 102.0 kg (IQR 94.0-124.6), which was not statistically significantly different from the 106.1 kg at baseline (IQR 99.0-128.4). Median BMI changed from 33.1 kg/m2 (IQR 32.3-38.5) at baseline to 33.7 kg/m2 (IQR 31.2-36.9) after follow-up. Patients had a TWL of 2.2% (IQR - 1.3-5.6) compared to baseline weight. None of the parameters were significantly different after follow-up compared to baseline. CONCLUSIONS: The effect of weight reduction of initial DJBL treatment seems to be diminished after 4 years of follow-up. However, larger prospective studies with long-term follow-up need to be conducted in the future.

The Effect of 6 and 12 months Duodenal-Jejunal Bypass Liner Treatment on Obesity and Type 2 Diabetes: a Crossover Cohort Study.

OBJECTIVE: The aim of this research was to study the duodenal-jejunal bypass liner (DJBL) treatment for obesity and type 2 diabetes mellitus (T2DM) in patients after dietary treatment in a cross-over design. BACKGROUND: DJBL treatment has been proven effective for treatment of obesity and T2DM. However, data on safety and efficacy of a 12-month DJBL treatment is limited. METHODS: In 2014, our research group reported on a multicenter randomized clinical trial. Patients were randomized to DJBL or dietary treatment (control group). Twenty-eight patients crossed over after their dietary treatment and received up to 12 months of DJBL treatment. Patient visits were conducted at baseline, during DJBL treatment (1 week, 1-6, 9, 12 months) and 6 months after removal of the liner. Patients underwent a standard physical examination, blood sampling, assessment of adverse events, nutritional and diabetes counseling, and a standardized meal tolerance test. RESULTS: Of the 28 patients included in this study, 24 patients completed 6 months of treatment. Eighteen patients were extended to 12 months of DJBL treatment; 13 patients completed this treatment period. After 6 months of DJBL treatment, a significant increase in excess weight loss (EWL) and decrease in weight, BMI, HbA1c, fasting glucose, cholesterol, HDL and LDL improved significantly. After 12 months of DJBL treatment, these parameters stabilized. CONCLUSIONS: The DJBL is an effective, minimally invasive treatment option. Even after successful treatment with dietary restrictions, the DJBL is still capable of significantly reducing weight and improving cardiovascular and type 2 diabetes mellitus parameters in obese patients.

Effect of Vagus Nerve Injury on the Outcome of Antireflux Surgery: An Extensive Literature Review.

BACKGROUND: Vagus nerve injury (VNI) is a feared complication of antireflux surgery (ARS). The impact of VNI on the functional outcomes of ARS has not yet been evaluated systematically. The aim of this review was to evaluate the impact of VNI on functional and clinical outcome of ARS. METHODS: A systematic search was performed until March 2015, using the following online databases: MEDLINE, Embase and the Cochrane Register of Controlled Clinical Trials. Eight studies remained available for assessment. Articles were divided into 2 groups: (a) one with unintended, accidental VNI and (b) one group comparing ARS with and without intended vagotomy. RESULTS: The prevalence of unintended, accidental VNI ranged from 10 to 42% after ARS. No clear differences were seen in outcome for reflux control between the VNI and vagus nerve intact group. A higher prevalence of diarrhea, nausea and vomiting was observed in the VNI group. CONCLUSION: VNI is a feared but neglected complication of ARS. Larger prospective studies that objectively assess vagus nerve integrity before and after ARS are needed.

Structural Endoscopic Techniques to Treat Obesity: A Review.

The prevalence of overweight and obesity increased significantly during the past decades, affecting now approximately 30% of people worldwide. Bariatric surgery has proven to be the most effective treatment modality for obesity in the long term. However, current surgical procedures are accompanied by a substantial risk of complications. Several endoluminal techniques have been developed to achieve weight loss in obese patients and claim to be as effective as surgery but safer. The aim of this review is to evaluate the efficacy and safety of endoscopic bariatric procedures that provide structural changes in anatomy and physiology of the gastrointestinal tract. A comprehensive search was conducted using online databases and the references of the selected articles. All studies included in this review show excess weight loss in the short-term to medium-term, which ranges from 24% to 58%. Seven serious adverse events were reported. Therefore, we conclude that endoscopic bariatric procedures providing structural changes show relatively low complication rates and promising short-term weight loss and effect on obesity-related comorbidities. Long-term results in large study populations are necessary before these techniques can be incorporated in the standard treatment of obesity.

A new poly(1,3-trimethylene carbonate) film provides effective adhesion reduction after major abdominal surgery in a rat model.

BACKGROUND: Postoperative adhesions remain a major clinical problem after abdominal surgery. We evaluated the efficacy of a new poly(trimethylene carbonate) (PTMC) film as an antiadhesive material. In many abdominal operations, there is an increased risk of fecal contamination; the risk of (increased) infection in presence of PTMC film was studied in 2 additional animal models. METHODS: A validated rat adhesion model with peritoneal ischemic buttons was used to compare the new PTMC film with a hyaluronate carboxymethylcellulose (HA-CMC) sheet, icodextrin solution, and a control group. Primary endpoint was occurrence of adhesions at the ischemic buttons after 14 days in 44 rats (n = 11 per group). To evaluate potential risks associated with the film, both an anastomotic leakage model and a cecal ligation and puncture model were used. Kruskal-Wallis tests with subsequent Mann-Whitney tests were used to detect differences between groups. RESULTS: PTMC film showed a significant reduction in the amount of adhesions (median, 0.5 buttons) compared with control group (median, 4 buttons; P < .001) and icodextrin group (median, 4.5; P < .001). The amount of adhesions was similar to the HA-CMC group (median, 2; P = .04). The presence of the film did not increase the risk of anastomotic leakage or bacterial growth in a contaminated environment. CONCLUSION: The presence of a PTMC film leads to a significant reduction in the amount of adhesions after 14 days in an ischemic button rat model. Furthermore, this film was found to be safe in an animal model, even in complex abdominal operations with an increased risk of fecal contamination.