Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity.

Autor:	Lopez Nava G; Bariatric Endoscopy Unit, HM Sanchinarro Hospital, Madrid, Spain., Arau RT; Teknon Medical Center, Barcelona, Spain., Asokkumar R; Bariatric Endoscopy Unit, HM Sanchinarro Hospital, Madrid, Spain; Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore., Maselli DB; Mayo Clinic, Rochester, Minnesota., Rapaka B; Mayo Clinic, Rochester, Minnesota., Matar R; Mayo Clinic, Rochester, Minnesota., Bautista I; Bariatric Endoscopy Unit, HM Sanchinarro Hospital, Madrid, Spain., Espinos Perez JC; Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore., Bilbao AM; Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore., Jaruvongvanich V; Mayo Clinic, Rochester, Minnesota., Vargas EJ; Mayo Clinic, Rochester, Minnesota., Storm AC; Mayo Clinic, Rochester, Minnesota., Neto MG; Division of Gastrointestinal Endoscopy, ABC Medical School, São Paulo, Brazil; Sri Aurobindo Medical College, Indore, India., Abu Dayyeh BK; Mayo Clinic, Rochester, Minnesota. Electronic address: abudayyeh.barham@mayo.edu.
Jazyk:	angličtina
Zdroj:	Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [Clin Gastroenterol Hepatol] 2023 Jan; Vol. 21 (1), pp. 81-89.e4. Date of Electronic Publication: 2022 May 06.
DOI:	10.1016/j.cgh.2022.04.019
Abstrakt:	Background & Aims: The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. Methods: Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. Results: 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m 2 ) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P < .01). POSE 2.0 reduced maximum tolerated meal volume (P = .03) and was associated with increased fullness (P < .01) and improved eating behavior (P < .01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P < .01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. Conclusion: POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. Clinicaltrials: gov Identifier: NCT03721731. (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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