Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months.

BACKGROUND: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare. METHODS: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed. RESULTS: Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months. CONCLUSION: During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01448785.

Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.

OBJECTIVE: To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity. METHODS: This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m-2) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test. RESULTS: At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001). CONCLUSIONS AND RELEVANCE: This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.

[Benefit from bio-enteric Intra-gastric balloon (BIB) to modify lifestyle and eating habits in severely obese patients eligible for bariatric surgery]. / Utilità del palloncino intragastrico nel modificare le abitudini di vita del paziente affetto da obesità severa, candidabile alla chirurgia bariatrica.

AIM: The therapeutic model for severe obesity includes bariatric surgery, representing the safest way to keep weight down and to prevent relapses. The selection of patients for the most suitable type of surgery implies multidisciplinary approach (nutritionist, dietist, clinical psychologist and surgeon). The intragastric balloon may represent a relatively invasive method to help the medical team to select and prepare severely obese patients for restrictive bariatric surgery. METHODS: In our study we considered 48 severely obese patients: initial weight 111+/-14.8 kg, BMI 43+/-5.02, excess weight 77.47+/-16.14%. These patients have been treated with intragastric balloon (BIB) filled to a volume of 500 cc for 6 months. We considered variations induced by BIB treatment on a number of parameters--clinical, anthropometric, food intake, partition of nourishing elements and psychological and psychometric data. RESULTS: At the end of the treatment the patients showed significant reductions of excess weight (67.35+/-20.19%), of weight (103.4+/-16.72 kg) and food intake, without modification of the items in the EDI2 test, but with important motivational support for a change in life style between the beginning and the end of the treatment, clearly resulting from the medical, dietist and clinical-psychological follow-up. CONCLUSIONS: BIB is a relatively invasive means capable of modifying eating habits in the short term; it induces weight loss, may help to reduce the anaesthesiological risk and to foster a change in the patient's behaviour. In our experience treatment with BIB is useful from the educational point of view and can be used to select patients for bariatric surgery only within a multidisciplinary team. Further clinical studies are necessary.

Immunoreactive trypsinogen levels in pediatric patients with intestinal failure awaiting intestinal transplantation.

The aim of this study was to evaluate pancreatic function in total parenteral nutrition (TPN)-dependent children with permanent intestinal failure by measuring immunoreactive trypsinogen (IRT) levels. Between 1992 and 1996, 105 pediatric patients with permanent intestinal failure were referred to the Children's Hospital of Pittsburgh for small intestinal transplant evaluation. Serum samples were available from 55 of them. Ten suffered from intestinal pseudo-obstruction or microvillus inclusion disease, while 45 had short bowel syndrome (SBS). IRT levels were significantly higher (p < 0.001) in SBS patients (89.4 +/- 9.2 ng mL) compared to controls (43.4 +/- 5.6 ng/ nL) without liver, gastrointestinal, or kidney disease. IRT levels did not correlate with liver injury, length of bowel, or the cause of SBS. Five of 20 patients who underwent intestinal transplantation developed pancreatitis during a median post-operative follow up 15.4 months later. IRT levels failed to predict who would develop pancreatitis post-transplant. The data suggest that elevated plasma IRT levels are common among children with intestinal failure, but fail to identify patients at risk for pancreatitis post-transplant.

Quality of life of patients after intestinal transplantation.

BACKGROUND: Quality of life is an important consideration in evaluating new medical or surgical treatments. Intestinal transplantation is now available for patients with irreversible intestinal failure. We compared quality of life among patients with intestinal failure receiving home parenteral nutrition (HPN) to that among patients who underwent intestinal transplantation (ITx) at the University of Pittsburgh Medical Center. METHODS: The results of the Quality of Life Inventory, a self-administered questionnaire, were compared among 10 ITx recipients and 10 HPN patients. Change in quality of life was examined longitudinally over a 2-year period with repeat testing in four patients in each group. RESULTS: ITx recipients were evaluated at mean time of 2.7 years after transplantation and after a mean period of 5.3 years of intestinal failure. HPN patients were evaluated after a mean period of 5.1 years of intestinal failure and were similar to the transplant recipients in age, gender, race, social status, education, etiology, and duration of disease. Assessed quality of life was markedly similar between HPN-dependent patients and ITx recipients, with significant differences in only 2 of 25 domains, despite the difficult early postoperative course and complex management that accompany intestinal transplantation. In longitudinal follow-up (n=4), ITx recipients reported significant improvement in anxiety (P=0.02), sleep (P=0.03), and impulsiveness/control (P<0.001), reflecting a progressive adjustment to their posttransplant status. CONCLUSION: The quality of life in ITx recipients is similar to that in HPN-dependent patients. Quality of life among ITx recipients improves over time with decreased anxiety over physical functioning. Further research and efforts to improve quality of life in transplant recipients are needed.

Quality of life after small intestinal transplantation and among home parenteral nutrition patients.

BACKGROUND: The purpose of the study was to quantify changes in the quality of life of small bowel recipients before and after transplantation and of home parenteral nutrition (HPN)-dependent patients before and after therapy. We examined quality of life across multiple areas of function including physical, social, and emotional indices. METHODS: The Quality of Life Instrument in the form of a self-administered questionnaire was completed voluntarily by the recipients of small intestinal transplants and by a cohort of HPN-dependent patients. RESULTS: Small intestinal transplant recipients reported significant improvement in the quality of their life and function. They also rated their quality of life and function during the pretransplant, TPN-dependent period to be worse than before the development of chronic intestinal failure. Similarly, HPN recipients reported significant worsening across most areas of quality of life when they compared their premorbid period to the HPN-dependent state. CONCLUSIONS: TPN dependence causes significant impairment in the quality of life in most areas of functioning. In contrast, small intestinal transplantation restores the quality of life among recipients with functioning grafts.