S Morales-Conde1, I Alarcón Del Agua1, L Busetto2, F Favretti3, M Anselmino4, G M Rovera5, M Socas-Macias1, A Barranco-Moreno1, R Province-Azalde6, A J Torres7. 1. Innovation and Minimal Invasive Surgery Unit, Hospital Virgen del Rocio, Avda Manuel Siurot, S/N, 41010, Sevilla, Spain. 2. Department of Medicine - University of Padova, Center for the Study and the Integrated Management of Obesity, Clinica Medica 3 - Padova University Hospital, Via Giustiniani 2, 35128, Padova, Italy. 3. Primari Vicenza Regional Hospital, Casa di cura Eretenia, Viale Eretenio 12, 36100, Vicenza, Italy. 4. Bariatric Surgery Department, University Hospital Pisa, Via Roma, 67, 56126, Pisa, Italy. 5. Clinica San Luca Torino, Strada della Vetta 3, 10020, Torino, Italy. 6. IntraPace Inc., 169 S 12th St, San Jose, CA, 95112, USA. 7. Department of Surgery, Hospital Clínico San Carlos. Hospital Universitario Madrid Monteprincipe, Calle Profesor Martín Lagos s/n, 28040, Madrid, Spain. ajtorresgarcia@gmail.com.
Abstract
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.
RCT Entities:
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.
Entities:
Keywords:
Eating behavior; Gastric stimulation; Morbid obesity; Obesity; Weight loss
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