Safety experience with the duodenal-jejunal bypass liner: an endoscopic treatment for diabetes and obesity.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is a new, device-based endoscopic treatment for type 2 diabetes mellitus (T2DM) and obesity. OBJECTIVE: To report serious safety events of subjects treated with the DJBL while offering a simple guideline to mitigate risk. DESIGN: Single-center observational study. SETTING: Tertiary referral center. PATIENTS: For commercial use, patients were eligible for implantation of the DJBL when they met the following criteria: age 18 to 65 years, body mass index 28 to 45 kg/m(2), T2DM, and negative serum Helicobacter pylori test. INTERVENTIONS: Endoscopic implantation of the DJBL. MAIN OUTCOME MEASUREMENTS: Adverse events, serious adverse events, early explantation. RESULTS: Between October 2007 and January 2014, 152 of 165 planned implantations (92%) and 94 explantations were performed in our center. Significant weight loss and improvement in T2DM and other cardiovascular parameters were achieved. Early removal of the device occurred because of persistent GI symptoms in 16 patients (11%). Serious adverse events were observed in a subset of patients: 7 GI bleeds, 5 of which required early removal; 2 cases of pancreatitis; 1 case of hepatic abscess; and 1 obstruction of the sleeve. Explantation resulted in an esophageal tear in 2 cases. LIMITATIONS: Single-center study. CONCLUSION: The DJBL improves glycemic control while causing weight loss. The safety profile of the DJBL demonstrates a reasonable tolerability profile. However, serious safety adverse events can occur. Patient selection, expert use of the device at placement and removal, and the supportive care of an experienced multidisciplinary team are key for safe and effective use of the DJBL.

A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery.

BACKGROUND: Iron deficiency (ID) is one of the most common postoperative deficiencies that may develop after Roux-en-Y gastric bypass (RYGB). The optimal mode of treatment is uncertain. AIM: To compare the efficacy of oral ferrous fumarate (FF), oral ferrous gluconate (FG), and a single intravenous infusion of ferric carboxymaltose (FCM) in women with ID after RYGB. METHODS: Multicenter randomized controlled trial including 120 women with a serum ferritin <20 µg/l during follow-up after RYGB. They were randomized into three groups: 41 patients were treated with FF 200 mg three times a day (total daily dose: 195 mg elemental iron), 39 received FG 695 mg twice a day (total daily dose: 160 mg elemental iron) for three months, and 39 patients were treated with a single intravenous dose of FCM (1000 mg elemental iron). Serum ferritin levels were measured at six weeks, and three, six and twelve months after the start of supplementation. RESULTS: At three months, persistence of ID was observed in 29.4% and 42.4% of the patients treated with FF and FG, respectively, but in none of those treated with FCM (p < 0.001). Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM. Adverse effects were most common during oral treatment. CONCLUSION: In women developing ID after RYGB, a single dose of intravenous FCM is more effective and better tolerated than the standard treatment with either FF or FG. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE: The study was registered at clinicaltrials.gov under number NCT02271997.

Adequate Multivitamin Supplementation after Roux-En-Y Gastric Bypass Results in a Decrease of National Health Care Costs: a Cost-Effectiveness Analysis.

INTRODUCTION: Patients with morbid obesity undergoing metabolic surgery are prone to develop vitamin and mineral deficiencies, which may worsen in time. In order to prevent these deficiencies after metabolic surgery, all patients are advised to take daily multivitamin supplementation. The aim of the study was to assess the cost-effectiveness of specially developed multivitamins (WLS Forte®) for metabolic surgery and over-the-counter (standard) multivitamin supplementation (sMVS). METHODS: This cost-effectiveness analysis was preformed alongside an RCT for the Netherlands. Between June 2011 and March 2012, a total of 148 patients were randomized to one tablet daily of either WLS Forte® or sMVS. The patients were followed for 12 months. Data on costs within the health sector and outside the health sector were collected. The primary outcome is financial and logistic advantages, in terms of less patient visits to the outpatient department and the relevant costs to the employer due to absenteeism. RESULTS: In total, 10 (14%) patients in the WLS Forte® group versus 23 (30%) patients in the sMVS group developed a deficiency. The costs for the WLS forte® supplement were €38 versus €23 for sMVS. Additional return visits and associated costs for medical staff were the largest costs, up to 43% in the sMVS group. Total costs for supplementation with sMVS were €243 versus €134 for WLS Forte®. CONCLUSION: Preventing deficiencies with WLS Forte® seem initially more expensive than sMVS. However, treatment with WLS Forte® resulted in less vitamin and mineral deficiencies, which eventually resulted in less overall costs.

Preperitoneal Bupivacaine Infiltration Reduces Postoperative Opioid Consumption, Acute Pain, and Chronic Postsurgical Pain After Bariatric Surgery: a Randomized Controlled Trial.

INTRODUCTION: A multimodal pain treatment including local anesthetics is advised for perioperative analgesia in bariatric surgery. Due to obesity, bariatric surgery patients are at risk of respiratory complications. Opioid consumption is an important risk factor for hypoventilation. Furthermore, acute postoperative pain is an important risk factor for chronic postsurgical pain. In this study, we aimed to evaluate whether preperitoneal anesthesia with bupivacaine would reduce pain and opioid consumption after bariatric surgery. METHODS: One hundred adults undergoing laparoscopic bariatric surgery were randomized to receive either preperitoneal bupivacaine 0.5% or normal saline before incision. Postoperative opioid consumption, postoperative pain, and postoperative recovery parameters were assessed for the first 24 h after surgery. One year after surgery, chronic postsurgical pain and influence of pain on daily living were evaluated. RESULTS: Postoperative opioid consumption during the first hour after surgery was 2.8 ± 3.0 mg in the bupivacaine group, whereas in the control group, it was 4.4 ± 3.4 mg (p = 0.01). Pain scores were significantly reduced in this first hour at rest and at 6 h during mobilization on the ward. One year after surgery, the incidence of chronic postsurgical pain was 13% in the bupivacaine group versus 40% in the placebo group. CONCLUSION: This study shows that preperitoneal local anesthesia with bupivacaine results in a reduction in opioid consumption and postoperative pain and seems to lower the incidence rate of chronic postsurgical pain after laparoscopic bariatric surgery.

Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial.

Background: After Roux-en-Y gastric bypass (RYGB), patients often develop a vitamin B-12 deficiency. Objective: Our objective was to investigate whether oral supplementation increases and normalizes low vitamin B-12 concentrations (vitamin B-12 > 200 pmol/L) in RYGB patients as compared to intramuscular injections. Design: A randomized controlled trial in RYGB patients with subnormal serum B-12 concentrations was performed. One group (IM B-12) received bimonthly intramuscular hydroxocobalamin injections (2000 µg as loading dose and 1000 µg at follow-up) for 6 mo. The second group (oral B-12) received daily doses of oral methylcobalamin (1000 µg). Serum vitamin B-12 was determined at baseline (T0) and at 2 (T1), 4 (T2), and 6 mo (T3) after start of treatment. Concentrations of the secondary markers methylmalonic acid (MMA) and homocysteine (Hcy) were measured at T0 and T3. Results: Fifty patients were included and randomized, 27 in IM B-12 and 23 in oral B-12. The median vitamin B-12 concentration at T0 was 175 pmol/L (range: 114-196 pmol/L) for IM B-12 and 167 pmol/L (range: 129-199 pmol/L) for oral B-12. Vitamin B-12 normalized in all individuals, and there was no significant difference in vitamin B-12 between the two groups. MMA and Hcy concentrations decreased significantly after 6 mo within each group (P < 0.001 and P < 0.001 for MMA and P = 0.03 and P = 0.045 for Hcy, respectively). There was no significant difference between the groups at 6 mo for both MMA and Hcy (P = 0.53 and P = 0.79). Conclusion: The efficacy of oral vitamin B-12 supplementation was similar to that of hydroxocobalamin injections in the present study. Oral supplementation can be used as an alternative to hydroxocobalamin injections to treat RYGB patients with low values of serum vitamin B-12. This trial was registered at clinicaltrials.gov as NCT02270749.