Sleeve and Cruroplasty for Preventing De-novo Gastric Reflux

Not Applicable

Recruiting

• Conditions: Condition 1: severe obesity. Condition 2: Bariatric surgery status. Condition 3: Gastro-esophageal reflux disease without esophagitis. Condition 4: Gastro-esophageal reflux disease with esophagitis.; Morbid (severe) obesity due to excess calories; Bariatric surgery status; Gastro-esophageal reflux disease without esophagitis; Gastro-esophageal reflux disease with esophagitis; E66.01; Z98.84; K21.9; K21.0

• Registration Number: IRCT20201020049087N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Have indications for bariatric procedure according to ASMBS guideline (i.e. body mass index>40 kg/m2)
Normal gastroesophageal junction view on endoscopy
No hiatal hernia on endoscopy
H.pylori stool antigen negative
No history of gastroesophageal reflux disease symptoms
No history of consuming PPIs or antibiotics
Willingness to participate in this study
Age within 20-60 years old

Exclusion Criteria

Not willing to participate in this study
Pregnancy during the follow-up
Severe or uncontrolled psychological disease
Not respecting to the dietician and supplement use protocols
Not participating in postoperative follow-up visits
Not willing to do postoperative endoscopy
>20% lack in medical document data
Finding hiatal hernia during the operation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of GERD clinical manifestations. Timepoint: before-after the surgery. Method of measurement: Taking history of reflux symptoms e.g. heartburn, regurgitation.

Secondary Outcome Measures

Name	Time	Method
GERD-Quality of Life questionnaire score. Timepoint: change in score before-after the surgery. Method of measurement: GERD-QL questionnaire.;Evidence of reflux in gastroesophageal endoscopy. Timepoint: before-after the surgery. Method of measurement: gastroesophageal endoscopy.;Evidence of hiatal hernia in endoscopy. Timepoint: before-after surgery. Method of measurement: upper endoscopy.