Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

Morbid Obesity Clinical Trial

Official title:

The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951093
• Other study ID #: GASTROBESE-004
• Status: Completed
• Phase: N/A
• First received: August 2, 2009
• Last updated: February 25, 2014
• Start date: March 2007
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Clinica Gastrobese
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.

Description:

The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.

Esophageal syndromes were evaluated according to 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 was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH < 4 for at least 4% of the total monitoring time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Morbid obesity

• Acceptance to undergo open gastric bypass

Exclusion Criteria:

• Prior gastroesophageal surgery

• Achalasia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Gastric bypass
Open Silastic® ring Roux-en Y gastric bypass was performed through an upper midline incision. A gastric pouch was created by dividing the stomach with a 10-cm stapler from the lesser curvature (7 cm vertically from the cardia) to 1 cm to the left of the Hiss angle. The estimated volume of the gastric pouch was 20 to 30 ml that was banded with a 6.5 cm long Silastic® ring. A gastrojejunal anastomosis was performed with two-layers hand sewn absorbable suture over a 1.2 cm bougie distal to the ring, keeping an alimentary limb with 100 cm in length, and a biliopancreatic limb ranging 60 and 80 cm.

Locations

Country	Name	City	State
Brazil	Clínica Gastrobese	Passo Fundo	RS

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Gastrobese

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Presenting Reflux Symptoms	Prevalence of typical reflux syndrome 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 was used.	Before GBP, 6 months after GBP and 39 months after GBP	No
Primary	Number of Participants With Esophageal Injury	Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis	Before GBP, 6 months after GBP and 39 months after GBP	No
Primary	Number of Participants With Gastroesophageal Reflux Disease (GERD)	Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.	Before GBP, 6 months after GBP and 39 months after GBP	No
Primary	Total Esophageal Acid Exposure at 24h pH Monitoring	Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.	Before GBP, 6 months after GBP and 39 months after GBP	No
Primary	Esophageal Acid Exposure at 24h pH Monitoring in Upright Position	Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position	Before GBP, 6 months after GBP and 39 months after GBP	No
Primary	Esophageal Acid Exposure at 24h pH Monitoring in Supine Position	Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position	Before GBP, 6 months after GBP and 39 months after GBP	No
Primary	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.	Before GBP, 6 months after GBP and 39 months after GBP	No