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
Abstract
BACKGROUND

Transoral outlet reduction (TORe) is a minimally invasive endoscopic revision of Roux-en-Y gastric bypass (RYGB) for weight recurrence; however, little has been published on its clinical implementation in the community setting.

AIM

To characterize the safety and efficacy of TORe in the community setting for adults with weight recurrence after RYGB.

METHODS

This is a retrospective cohort study of argon plasma coagulation and purse-string suturing for gastric outlet reduction in consecutive adults with weight recurrence after RYGB at a single community center from September 2020 to September 2022. Patients were provided longitudinal nutritional support via virtual visits. The primary outcome was total body weight loss (TBWL) at twelve months from TORe. Secondary outcomes included TBWL at three months and six months; excess weight loss (EWL) at three, six, and twelve months; twelve-month TBWL by obesity class; predictors of twelve-month TBWL; rates of post-TORe stenosis; and serious adverse events (SAE). Outcomes were reported with descriptive statistics.

RESULTS

Two hundred eighty-four adults (91.9% female, age 51.3 years, body mass index 39.3 kg/m2) underwent TORe an average of 13.3 years after RYGB. Median pre- and post-TORe outlet diameter was 35 mm and 8 mm, respectively. TBWL was 11.7% ± 4.6% at three months, 14.3% ± 6.3% at six months, and 17.3% ± 7.9% at twelve months. EWL was 38.4% ± 28.2% at three months, 46.5% ± 35.4% at six months, and 53.5% ± 39.2% at twelve months. The number of follow-up visits attended was the strongest predictor of TBWL at twelve months (R2 = 0.0139, P = 0.0005). Outlet stenosis occurred in 11 patients (3.9%) and was successfully managed with endoscopic dilation. There was one instance of post-procedural nausea requiring overnight observation (SAE rate 0.4%).

CONCLUSION

When performed by an experienced endoscopist and combined with longitudinal nutritional support, purse-string TORe is safe and effective in the community setting for adults with weight recurrence after RYGB.

Keywords: Transoral outlet reduction, Purse-string, Roux-en-Y gastric bypass, Obesity, Endoscopic revision, Weight recurrence, Gastrojejunal anastomosis

Core Tip: Given the chronic, progressive nature of obesity, weight recurrence after Roux-en-Y gastric bypass (RYGB) is common. Transoral outlet reduction (TORe) is a minimally invasive, same-day, Food and Drug Administration-authorized endoscopic procedure that restricts the gastrojejunal anastomosis to facilitate safe and clinically meaningful weight loss in patients experiencing post-RYGB weight recurrence. To date, nearly all TORe literature has originated in the academic setting. Here, we show that TORe is safe, effective, and technically feasible in the community setting when performed by an experienced bariatric endoscopist and coupled with longitudinal aftercare.