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

NCT05365087 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-05-08

No results posted yet for this study

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

Interventions

PROCEDURE

Transoral Fundoplication and Sleeve Gastrectomy

Transoral Fundoplication procedure completed prior to Sleeve Gastrectomy

PROCEDURE

Gastric Bypass

Laparoscopic Roux-en-Y gastric bypass

Sponsors & Collaborators

  • Lexington Health Incorporated

    lead OTHER

Principal Investigators

  • Marc Antonetti, MD · Lexington Health Incorporated

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2032-12-31
Completion
2032-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365087 on ClinicalTrials.gov