Viewing Study NCT02012894


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Study NCT ID: NCT02012894
Status: COMPLETED
Last Update Posted: 2013-12-16
First Post: 2013-12-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux
Sponsor: University of Turin, Italy
Organization:

Study Overview

Official Title: Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy
Status: COMPLETED
Status Verified Date: 2013-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.

The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.
Detailed Description: Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: