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


Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775

Informations de publication

Date de publication:
01 2023
Historique:
received: 09 02 2022
revised: 18 04 2022
accepted: 20 04 2022
pubmed: 10 5 2022
medline: 27 12 2022
entrez: 9 5 2022
Statut: ppublish

Résumé

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. 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. 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m 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. gov Identifier: NCT03721731.

Sections du résumé

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
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.

Identifiants

pubmed: 35533995
pii: S1542-3565(22)00444-X
doi: 10.1016/j.cgh.2022.04.019
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT03721731']

Types de publication

Multicenter Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

81-89.e4

Informations de copyright

Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.

Auteurs

Gontrand Lopez Nava (G)

Bariatric Endoscopy Unit, HM Sanchinarro Hospital, Madrid, Spain.

Roman Turro Arau (RT)

Teknon Medical Center, Barcelona, Spain.

Ravishankar Asokkumar (R)

Bariatric Endoscopy Unit, HM Sanchinarro Hospital, Madrid, Spain; Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.

Daniel B Maselli (DB)

Mayo Clinic, Rochester, Minnesota.

Babusai Rapaka (B)

Mayo Clinic, Rochester, Minnesota.

Reem Matar (R)

Mayo Clinic, Rochester, Minnesota.

Inmaculada Bautista (I)

Bariatric Endoscopy Unit, HM Sanchinarro Hospital, Madrid, Spain.

Jorge Carlos Espinos Perez (JC)

Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.

Alfredo Mata Bilbao (AM)

Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.

Veeravich Jaruvongvanich (V)

Mayo Clinic, Rochester, Minnesota.

Eric J Vargas (EJ)

Mayo Clinic, Rochester, Minnesota.

Andrew C Storm (AC)

Mayo Clinic, Rochester, Minnesota.

Manoel Galvao Neto (MG)

Division of Gastrointestinal Endoscopy, ABC Medical School, São Paulo, Brazil; Sri Aurobindo Medical College, Indore, India.

Barham K Abu Dayyeh (BK)

Mayo Clinic, Rochester, Minnesota. Electronic address: abudayyeh.barham@mayo.edu.

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Classifications MeSH