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Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass

Primary Purpose

Gastroesophageal Reflux Disease, Morbid Obesity

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Roux-en-Y Gastric Bypass

Vertical Sleeve Gastrectomy

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

BMI > 40 Kg/m2, or BMI > 35 Kg/m2 along with clinical comorbidities (such as Diabetes Mellitus, Systemic Arterial Hypertension or Articular Lesions)
Been unable to loose or sustain weight loss after 2 years medical and nutritional treatments.

Exclusion Criteria:

Been previously submitted to any gastroesophageal surgical procedure
Presence of chronical diseases that affects esophageal motility
Do not tolerate any of the required exams

Sites / Locations

Gastrobese Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BPG Group

Sleeve Group

Arm Description

Patients will be submitted to Roux-en-Y Bypass Gastric Surgery.

Patients will be submitted to Vertical Sleeve Gastrectomy Surgery.

Outcomes

Primary Outcome Measures

Change in number of Participants With Gastroesophageal Reflux Disease (GERD)

Prevalence of GERD in patients will be characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.

Secondary Outcome Measures

Change in number of Participants Presenting Reflux Symptoms

Prevalence of typical reflux syndrome as classified according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language will be used.

Change in number of Participants With Esophageal Injury

Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis

Change in Total Esophageal Acid Exposure at 24h pH Monitoring

Esophageal acid exposure will be measured through 24h pH monitoring. During such period, esophageal pH will be measured and recorded as the percent of time pH stays below 4.

Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position

Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in upright position

Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position

Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in supine position

Change in number of Participants With Increased Acid Exposure

Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring.

Full Information

NCT ID

NCT03692455

First Posted

December 21, 2015

Last Updated

September 28, 2018

Sponsor

Clinica Gastrobese

1. Study Identification

Unique Protocol Identification Number

NCT03692455

Brief Title

Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass

Official Title

Clinico-functional Evaluation of Gastroesophageal Reflux Disease (GERD): A Comparative Study Between the Vertical Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Techniques

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 19, 2016 (Actual)

Primary Completion Date

August 13, 2018 (Actual)

Study Completion Date

August 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clinica Gastrobese

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The hypothesis of this study is that surgical techniques primarily designed for weight loss, ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients. Therefore the present study intends to evaluate such impact on patients submitted to two of the most common techniques available, the Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy.

Detailed Description

In order to determine if weight loss surgeries do indeed ameliorate GERD in morbidly obese patients, esophageal syndromes will be evaluated following the Montreal Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy. Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid exposure will be characterized when total esophageal pH < 4 for at least 4% of its total monitoring time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease, Morbid Obesity

Keywords

GERD, Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BPG Group

Arm Type

Experimental

Arm Description

Patients will be submitted to Roux-en-Y Bypass Gastric Surgery.

Arm Title

Sleeve Group

Arm Type

Experimental

Arm Description

Patients will be submitted to Vertical Sleeve Gastrectomy Surgery.

Intervention Type

Procedure

Intervention Name(s)

Roux-en-Y Gastric Bypass

Other Intervention Name(s)

GBP

Intervention Description

The Roux-en-Y gastric bypass procedure involves creating a stomach pouch out of a small portion of the stomach and attaching it directly to the small intestine, bypassing a large part of the stomach and duodenum. Not only is the stomach pouch too small to hold large amounts of food, but by skipping the duodenum, fat absorption is substantially reduced.

Intervention Type

Procedure

Intervention Name(s)

Vertical Sleeve Gastrectomy

Other Intervention Name(s)

Sleeve

Intervention Description

VSG surgery restricts food intake and decreases the amount of food used. Most of the stomach is removed during this surgery, which may decrease ghrelin, a hormone that prompts appetite. Lower amounts of ghrelin may reduce hunger more than other purely restrictive surgeries, such as AGB.

Primary Outcome Measure Information:

Title

Change in number of Participants With Gastroesophageal Reflux Disease (GERD)

Description

Prevalence of GERD in patients will be characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.

Time Frame

Before Intervention, 1 year after intervention

Secondary Outcome Measure Information:

Title

Change in number of Participants Presenting Reflux Symptoms

Description

Time Frame

Before Intervention, 1 year after Intervention

Title

Change in number of Participants With Esophageal Injury

Description

Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis

Time Frame

Before Intervention, 1 year after intervention

Title

Change in Total Esophageal Acid Exposure at 24h pH Monitoring

Description

Esophageal acid exposure will be measured through 24h pH monitoring. During such period, esophageal pH will be measured and recorded as the percent of time pH stays below 4.

Time Frame

Before Intervention, 1 year after intervention

Title

Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position

Description

Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in upright position

Time Frame

Before Intervention, 1 year after intervention

Title

Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position

Description

Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in supine position

Time Frame

Before Intervention, 1 year after intervention

Title

Change in number of Participants With Increased Acid Exposure

Description

Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring.

Time Frame

Before Intervention, 1 year after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: BMI > 40 Kg/m2, or BMI > 35 Kg/m2 along with clinical comorbidities (such as Diabetes Mellitus, Systemic Arterial Hypertension or Articular Lesions) Been unable to loose or sustain weight loss after 2 years medical and nutritional treatments. Exclusion Criteria: Been previously submitted to any gastroesophageal surgical procedure Presence of chronical diseases that affects esophageal motility Do not tolerate any of the required exams

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos Augusto S Madalosso, PhD

Organizational Affiliation

Gastrobese Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gastrobese Clinic

City

Passo Fundo

State/Province

ZIP/Postal Code

99010-112

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass

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