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NCT05365087 · ClinicalTrials.gov registry record
Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients
A clinical trial of Gastroesophageal Reflux Disease, sponsored by Lexington Health Incorporated.
- Active
- Registry status
- 180
- Enrollment target
- 1
- Study location
NCT05365087: Active study of Gastroesophageal Reflux Disease, sponsored by Lexington Health Incorporated.
NCT05365087 is a study of Gastroesophageal Reflux Disease that is active but no longer recruiting, run by Lexington Health Incorporated. The registered enrollment target is 180 participants, below the 349-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05365087, a study of Gastroesophageal Reflux Disease, is active but no longer recruiting, sponsored by Lexington Health Incorporated.
- ACTIVE NOT RECRUITING
- Registry status
- 180 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Transoral Fundoplication and Sleeve Gastrectomy
- PROCEDURE Gastric Bypass
Study Locations (1)
South Carolina
- Lexington Health Incorporated - West Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2032-12-31 |
What the registry record for NCT05365087 still lists
NCT05365087 is an observational study that tracks outcomes without assigning an intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 349-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 2 interventions - of which Transoral Fundoplication and Sleeve Gastrectomy is the first listed.
NCT05365087 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT05365087 about?
NCT05365087 is a clinical study titled "Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients". 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 th...
What is the current status of trial NCT05365087?
This trial is currently active not recruiting. The enrollment target is 180 participants. The study started on 2018-03-01. Estimated completion is 2032-12-31.
What conditions does trial NCT05365087 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease.
What interventions are being tested in trial NCT05365087?
The interventions under investigation include: Transoral Fundoplication and Sleeve Gastrectomy (PROCEDURE), Gastric Bypass (PROCEDURE).
Who is sponsoring clinical trial NCT05365087?
This trial is sponsored by Lexington Health Incorporated, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05365087 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05365087's enrollment target sits among peer trials
180 9th of 25 higher than 17 of 25 other Gastroesophageal Reflux Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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