- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692455
Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass
Clinico-functional Evaluation of Gastroesophageal Reflux Disease (GERD): A Comparative Study Between the Vertical Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Techniques
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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RS
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Passo Fundo, RS, Brazil, 99010-112
- Gastrobese Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BPG Group
Patients will be submitted to Roux-en-Y Bypass Gastric Surgery.
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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.
Other Names:
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Experimental: Sleeve Group
Patients will be submitted to Vertical Sleeve Gastrectomy Surgery.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of Participants With Gastroesophageal Reflux Disease (GERD)
Time Frame: Before Intervention, 1 year after intervention
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Prevalence of GERD in patients will be characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.
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Before Intervention, 1 year after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Before Intervention, 1 year after Intervention
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Change in number of Participants With Esophageal Injury
Time Frame: Before Intervention, 1 year after intervention
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Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis
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Before Intervention, 1 year after intervention
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Change in Total Esophageal Acid Exposure at 24h pH Monitoring
Time Frame: Before Intervention, 1 year after intervention
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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.
|
Before Intervention, 1 year after intervention
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Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
Time Frame: Before Intervention, 1 year after intervention
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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
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Before Intervention, 1 year after intervention
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Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
Time Frame: Before Intervention, 1 year after intervention
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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
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Before Intervention, 1 year after intervention
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Change in number of Participants With Increased Acid Exposure
Time Frame: Before Intervention, 1 year after intervention
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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.
|
Before Intervention, 1 year after intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Augusto S Madalosso, PhD, Gastrobese Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PP3
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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