Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients

NCT05365087 | Active Not Recruiting

• 1 other identifier: LMC2021-1001
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective and prospective cohort study to compare the effect of completing a Transoral Fundoplication procedure prior to Laparoscopic Sleeve Gastrectomy surgery to Laparoscopic Roux-en-Y Gastric Bypass in bariatric patients with Gastroesophageal Reflux Disease signs and symptoms. The aim of this study is to examine the effect of TF prior to sleeve gastrectomy as compared to Roux-en-Y Gastric Bypass on reflux symptoms in bariatric patients. Additional Follow up data until 10 years will be collected to evaluate for sequelae of GERD.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Outcome Measures

Primary Outcomes (1)

• Measure change in reflux symptoms, impact of symptoms, and satisfaction of current status with the Gastroesophageal Reflux Disease Health Related Quality of Life GERD HRQL-RSI Questionnaire

  The GERD HRQL-RSI Questionnaire quantifies the symptoms of reflux the patient experiences, as well as the impact of symptoms on their daily life, and their satisfaction with their current status. The questionnaire also evaluates reflux medication use, which is another measure of treatment effectiveness. Items are rated on a scale of 0-5. The lowest possible score equals no symptoms.

  TS Cohort : Initial consultation, up to 6 weeks post fundoplication, up to 6 months post sleeve gastrectomy. RNY Cohort : At initial consultation, up to 6 months post RNY

Secondary Outcomes (1)

• Measure change in Body Mass Index, BMI

  TS Cohort: Initial Consultation, up to 6 weeks post fundoplication, up to 6 months post sleeve gastrectomy, 12 months post LSG. For the RNY Cohort, Initial Consultation and up to 6 months post RNY and 12 month post RNY.

Study Arms (3)

TS Cohort

Patients who chose the Transoral Fundoplication TF prior to the Laparoscopic Sleeve Gastrectomy LSG procedure.

Procedure: Transoral Fundoplication and Sleeve Gastrectomy

RNY Cohort

Patients who chose the Laparoscopic Roux-enY Gastric Bypass procedure.

Procedure: Gastric Bypass

LSG Cohort

Patients with no evidence of GERD who undergo LSG and complete standard surveillance endoscopy

Interventions

Transoral Fundoplication and Sleeve Gastrectomy PROCEDURE

Transoral Fundoplication procedure completed prior to Sleeve Gastrectomy

TS Cohort

Gastric Bypass PROCEDURE

Laparoscopic Roux-en-Y gastric bypass

RNY Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen for bariatric surgery consultation who report a history or current symptoms of GERD, or who are taking some form of medication for treatment of GERD, are asked to complete the Gastroesophageal Reflux Disease-Health Related Quality of Life Questionnaire GERD-HRQL. The GERD-HRQL is a validated, reliable and practical standard instrument which assesses the impact and severity of reflux symptoms on a patient's quality of life. The use of the GERD-HQRL for this purpose reflects a standard of care in the evaluation of any patient presenting with GERD symptoms.

You may qualify if:

• Bariatric patients who have documented GERD per GERD-HRQL at initial consultation and confirmed by preoperative testing
• bariatric patients who received or plan to have the TF procedure prior to Sleeve Gastrectomy
• bariatric patients who underwent or plan to undergo Roux-en-Y Gastric Bypass
• Male or female
• Ages 18 or older
• Bariatric patients who have no evidence of GERD per GERD-HRQL at initial consultation or on preoperative testing.
• bariatric patients who received or plan to undergo LSG and who complete surveillance endoscopy one year postoperatively

You may not qualify if:

• Incomplete records missing any component of the demographic data to be analyzed
• Patients who undergo Roux-en-Y Gastric Bypass conversion from Sleeve Gastrectomy

Sponsors & Collaborators

• Lexington Health Incorporated: lead

Study Sites (1)

Lexington Health Incorporated

West Columbia, South Carolina, 29169, United States

Location

Related Publications (6)

• Barr AC, Frelich MJ, Bosler ME, Goldblatt MI, Gould JC. GERD and acid reduction medication use following gastric bypass and sleeve gastrectomy. Surg Endosc. 2017 Jan;31(1):410-415. doi: 10.1007/s00464-016-4989-4. Epub 2016 Jun 10.

  PMID: 27287901 BACKGROUND

• DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014 Apr;149(4):328-34. doi: 10.1001/jamasurg.2013.4323.

  PMID: 24500799 BACKGROUND

• Rondelli F, Bugiantella W, Vedovati MC, Mariani E, Balzarotti Canger RC, Federici S, Guerra A, Boni M. Laparoscopic gastric bypass versus laparoscopic sleeve gastrectomy: A retrospective multicenter comparison between early and long-term post-operative outcomes. Int J Surg. 2017 Jan;37:36-41. doi: 10.1016/j.ijsu.2016.11.106. Epub 2016 Nov 29.

  PMID: 27913235 BACKGROUND

• Tai CM, Huang CK. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Oct;27(10):3937. doi: 10.1007/s00464-013-3022-4. Epub 2013 May 25. No abstract available.

  PMID: 23708727 BACKGROUND

• Testoni PA, Testoni S, Mazzoleni G, Vailati C, Passaretti S. Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Surg Endosc. 2015 Sep;29(9):2770-80. doi: 10.1007/s00464-014-4008-6. Epub 2014 Dec 6.

  PMID: 25480624 BACKGROUND

• Trad KS, Turgeon DG, Deljkich E. Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms. Surg Endosc. 2012 Mar;26(3):650-60. doi: 10.1007/s00464-011-1932-6. Epub 2011 Sep 30.

  PMID: 21959689 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Marc Antonetti, MD

  Lexington Health Incorporated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: May 9, 2022
• Study Start: March 1, 2018
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: A date relative to the time when summary data are published.

Locations

US (1)