Status:
ACTIVE_NOT_RECRUITING
Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients
Lead Sponsor:
Lexington Health Incorporated
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
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...
Detailed Description
Gastroesophageal Reflux Disease or GERD is a common condition that produces discomfort and can result in serious sequelae from frequent esophageal acid exposure, including Barrett's esophagus, erosive...
Eligibility Criteria
Inclusion
- 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
- Incomplete records missing any component of the demographic data to be analyzed
- Patients who undergo Roux-en-Y Gastric Bypass conversion from Sleeve Gastrectomy
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2032
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05365087
Start Date
March 1 2018
End Date
December 31 2032
Last Update
May 8 2025
Active Locations (1)
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1
Lexington Health Incorporated
West Columbia, South Carolina, United States, 29169