Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Mayo Clinic200 enrolled

Overview

Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

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 gastroesophageal reflux disease. Subjects will undergo a repeat upper endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after surgery and complete questionnaires during follow-ups up to 5 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Gastroesophageal Reflux Sleeve Gastrectomy Bariatric Surgery Complication

Interventions

EndoFLIP measurementDEVICE

EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (2)

Orlando Health

Orlando, Florida, United States

ACTIVE_NOT_RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Worsening or new-onset gastroesophageal reflux disease

Determined by the change in the GERD-Health Related Quality of Life questionnaire score with questions individually scored on a scale of 0-5, combined to determine a total score range of 0-75 where a higher score indicates worse quality of life and increased score would indicate new or worsening GERD.

Time frame: Baseline, 6 months, and 5 years

Central Contacts

Elizabeth Lemke

CONTACT

5072663317 Lemke.Elizabeth@mayo.edu

Data from ClinicalTrials.gov

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