Status:
RECRUITING
Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
Lead Sponsor:
Mayo Clinic
Conditions:
Gastroesophageal Reflux
Sleeve Gastrectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.
Detailed Description
Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters from endoscopy and EndoFLIP device to develop a prediction model for post-operative gastroesophag...
Eligibility Criteria
Inclusion
- Adult patients \> 18 years
- BMI 30 or greater kg/m2
- Participants can give a consent to the procedure
- Participants have no contraindications to LSG (gastric ulceration)
Exclusion
- Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture.
- Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)
- Patients with hiatal hernia \> 3 cm
- Patients with previous esophageal or stomach surgery
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04411823
Start Date
February 1 2021
End Date
October 1 2028
Last Update
February 18 2025
Active Locations (2)
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1
Orlando Health
Orlando, Florida, United States, 32806
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905