Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

  • STATUS
    Recruiting
  • End date
    Jul 1, 2026
  • participants needed
    200
  • sponsor
    Mayo Clinic
Updated on 8 August 2021

Summary

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

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

Details
Condition Gastroesophageal Reflux, Gastroesophageal Reflux Disease (GERD), Sleeve Gastrectomy, gastroesophageal reflux disease, esophageal reflux, gerd, gastric reflux, gastro-oesophageal reflux, Bariatric Surgery Complication
Treatment EndoFLIP measurement
Clinical Study IdentifierNCT04411823
SponsorMayo Clinic
Last Modified on8 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients > 18 years
BMI over 30 kg/m2 and stable weight for 3 months before the procedure
Participants can give a consent to the procedure
Participants have no contraindications to LSG (anticoagulation, gastric ulceration, hiatal hernia of > 5 cm)

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
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