Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

December 10, 2013 updated by: Fabrizio Rebecchi, University of Turin, Italy

Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • University of Turin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive morbidly obese patients selected for LSG

Description

Inclusion Criteria:

  • history of obesity exceeding 5 years
  • documented previous weight loss attempts,
  • body mass index (BMI)) of 40-50 kg/m2
  • age of 18-60 years.

Exclusion Criteria:

  • contraindications to pneumoperitoneum
  • large esophageal hiatal hernia
  • pregnancy,
  • drug or alcohol abuse,
  • psychological disorders (e.g., bulimia, depression)
  • hormonal or genetic obesity-related disease,
  • previous gastric surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Obese patients with preoperative GER
Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A)
Obese patients without preoperative GER
Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in DeMeester's score
Time Frame: baseline, 24 months after LSG
Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes
baseline, 24 months after LSG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in lower esophageal sphincter pressure
Time Frame: baseline, 24 months after LSG
Esophageal manometry measures several parameters including lower esophageal sphincter pressure
baseline, 24 months after LSG
Change from baseline in amplitude of esophageal peristaltic waves
Time Frame: baseline, 24 months after LSG
Esophageal manometry evaluates quality and amplitude of esophageal peristalsis
baseline, 24 months after LSG
Change from baseline in grade of esophagitis
Time Frame: baseline, 24 months after LSG
Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis
baseline, 24 months after LSG
Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score
Time Frame: Baseline, 24 months after LSG
Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life
Baseline, 24 months after LSG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Fabrizio Rebecchi, MD, University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Estimate)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGEOB/76

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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