Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
EndoFLIP measurement
DeviceEndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov