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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: August 13, 2018

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.

Interventions

  • Procedure: Roux-en-Y Gastric Bypass
    • 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.
  • Procedure: Vertical Sleeve Gastrectomy
    • 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.

Arms, Groups and Cohorts

  • Experimental: BPG Group
    • Patients will be submitted to Roux-en-Y Bypass Gastric Surgery.
  • Experimental: Sleeve Group
    • Patients will be submitted to Vertical Sleeve Gastrectomy Surgery.

Clinical Trial Outcome Measures

Primary Measures

  • Change in number of Participants With Gastroesophageal Reflux Disease (GERD)
    • Time Frame: Before Intervention, 1 year after intervention
    • Prevalence of GERD in patients will be characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.

Secondary Measures

  • Change in number of Participants Presenting Reflux Symptoms
    • Time Frame: Before Intervention, 1 year after Intervention
    • 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
    • Time Frame: Before Intervention, 1 year after intervention
    • Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis
  • Change in Total Esophageal Acid Exposure at 24h pH Monitoring
    • Time Frame: Before Intervention, 1 year after intervention
    • 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
    • Time Frame: Before Intervention, 1 year after intervention
    • 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
    • Time Frame: Before Intervention, 1 year after intervention
    • 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
    • Time Frame: Before Intervention, 1 year after intervention
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clinica Gastrobese
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carlos AS Madalosso, Clinical Director – Clinica Gastrobese
  • Overall Official(s)
    • Carlos Augusto S Madalosso, PhD, Principal Investigator, Gastrobese Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.