Retrospective Cohort Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Oct 16, 2023; 15(10): 602-613
Published online Oct 16, 2023. doi: 10.4253/wjge.v15.i10.602
Transoral outlet reduction: Outcomes of endoscopic Roux-en-Y gastric bypass revision in 284 patients at a community practice
Daniel B Maselli, Vibhu Chittajallu, Chase Wooley, Areebah Waseem, Daniel Lee, Michelle Secic, Lauren L Donnangelo, Brian Coan, Christopher E McGowan
Daniel B Maselli, Lauren L Donnangelo, Clinical Research, True You Weight Loss, Atlanta, GA 30342, United States
Vibhu Chittajallu, Department of Gastroenterology and Hepatology, University Hospitals Cleveland Medical Center, Cleveland, OH 44106, United States
Chase Wooley, Areebah Waseem, Daniel Lee, Brian Coan, Christopher E McGowan, Clinical Research, True You Weight Loss, Cary, NC 27513, United States
Michelle Secic, Secic Statistical Consulting, Cleveland, OH 44106, United States
Author contributions: Maselli DB protocol preparation, manuscript preparation and revision; Chittajallu V manuscript preparation; Waseem A protocol preparation, manuscript revision; Lee D data collection, manuscript revision; Secic M statistical analysis; Wooley C protocol preparation, manuscript revision; Donnangelo LL manuscript revision; Coan B manuscript revision; McGowan CE study conceptualization, protocol preparation, manuscript revision.
Institutional review board statement: The study was approved by an Institutional Review Board (WCG IRB, Puyallup, WA).
Informed consent statement: All subjects provided signed consent for their data to be used for scientific publication.
Conflict-of-interest statement: Dr. Daniel B Maselli is a consultant for Apollo Endosurgery, with no proprietary relationship. Dr. Christopher E McGowan previously served as a consultant for Apollo Endosurgery from 2019-2022, with no proprietary relationship. Dr. Vibhu Chittajallu, Dr. Lauren L Donnangelo, Dr. Brian Coan, Mr. Chase Wooley, Ms. Areebah Waseem, Ms. Michelle Secic, and Mr. Daniel Lee have no conflicts of interest or financial ties to disclose.
Data sharing statement: Data can be made available from the corresponding author at drmcgowan@trueyouweightloss.com.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Christopher E McGowan, AGAF, FASGE, MD, Director, Clinical Research, True You Weight Loss, 2001 Weston Pkwy, Cary, NC 27513, United States. drmcgowan@trueyouweightloss.com
Received: July 31, 2023
Peer-review started: July 31, 2023
First decision: August 24, 2023
Revised: August 28, 2023
Accepted: September 11, 2023
Article in press: September 11, 2023
Published online: October 16, 2023
Processing time: 72 Days and 9.3 Hours
ARTICLE HIGHLIGHTS
Research background

Given the chronic, progressive nature of obesity, recurrence of 20%-30% of weight lost is common in the decade following Roux-en-Y gastric bypass (RYGB).

Research motivation

Surgical interventions for weight recurrence after RYGB carry heightened risks. Patients may be more amenable to the minimally-invasive endoscopic revision known as transoral outlet reduction (TORe). Though United States Food and Drug Administration-authorized, very little data exists on the implementation of TORe in the community setting.

Research objectives

To clarify the safety, efficacy, and technically feasibility of purse-string TORe in the community setting.

Research methods

This was a retrospective evaluation of a prospectively-maintained cohort of adult patients undergoing purse-string TORe in an ambulatory surgical center at a practice with expertise in endoscopic bariatric therapies. The primary outcome was total body weight loss at 12 mo. Secondary outcomes included excess weight loss within the first year, safety, predictors of total body weight loss (TBWL) response at 12 mo, and rates of post-TORe gastrojejunal anastomosis (GJA) stenosis.

Research results

In this cohort of 284 adults who underwent TORe in the community setting for weight recurrence following RYGB, 12-mo total body weight loss was 17.4%, and 81.2% achieved ≥ 10% TBWL. The number of follow up visits was the strongest predictor of 12-mo TBWL. Serious adverse events were rare and included one episode of post-operative nausea and vomiting requiring hospitalization (0.4%). Post-TORe stenosis occurred in 3.9% of subjects after an average of 57 d from TORe and was successfully managed with 1-2 endoscopic dilations. In this single largest cohort of patients undergoing TORe with a consistent purse-string technique, the procedure was shown to be safe and effective in the community setting.

Research conclusions

When performed by experienced endoscopists and supported by longitudinal nutritional aftercare, purse-string TORe is an effective, safe, and feasible tool in the community setting to address weight recurrence after RYGB.

Research perspectives

Further study of TORe should evaluate the impact of the procedure on weight related comorbidities, which are shown to reemerge with weight recurrence after RYGB. Investigation into application of TORe to other metabolic and bariatric surgeries with a GJA (such as the one-anastomosis gastric bypass) and other clinical entities in RYGB (such as dumping syndrome and bile acid reflux) will also be valuable to the field.