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

United States180 participantsStarted 2018-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Bariatric patients who have documented GERD per GERD-HRQL at initial consultation and confirmed by preoperative testing * 60 bariatric patients who received or plan to have the TF procedure prior to Sleeve Gastrectomy * 60 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. * 60 bariatric patients who received or plan to undergo LSG and who complete surveillance endoscopy one year postoperatively Exclusion Criteria: * Incomplete records missing any component of the demographic data to be analyzed * Patients who undergo Roux-en-Y Gastric Bypass conversion from Sleeve Gastrectomy

What they're measuring

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

Timeframe: 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

Trial details

NCT IDNCT05365087

SponsorLexington Health Incorporated

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2032-12-31

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