Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass
- Conditions
- Gastroesophageal Reflux DiseaseMorbid Obesity
- Interventions
- Procedure: Vertical Sleeve GastrectomyProcedure: Roux-en-Y Gastric Bypass
- Registration Number
- NCT03692455
- Lead Sponsor
- Clinica Gastrobese
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
- 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.
- Been previously submitted to any gastroesophageal surgical procedure
- Presence of chronical diseases that affects esophageal motility
- Do not tolerate any of the required exams
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleeve Group Vertical Sleeve Gastrectomy Patients will be submitted to Vertical Sleeve Gastrectomy Surgery. BPG Group Roux-en-Y Gastric Bypass Patients will be submitted to Roux-en-Y Bypass Gastric Surgery.
- Primary Outcome Measures
Name Time Method Change in number of Participants With Gastroesophageal Reflux Disease (GERD) 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 Outcome Measures
Name Time Method Change in Total Esophageal Acid Exposure at 24h pH Monitoring 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 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 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 Esophageal Injury Before Intervention, 1 year after intervention Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis
Change in number of Participants With Increased Acid Exposure 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.
Change in number of Participants Presenting Reflux Symptoms 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.
Trial Locations
- Locations (1)
Gastrobese Clinic
🇧🇷Passo Fundo, RS, Brazil