Trial Outcomes & Findings for Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass (NCT NCT00951093)

NCT ID: NCT00951093

Last Updated: 2025-04-01

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 53 participants
• Primary outcome timeframe: Before GBP, 6 months after GBP and 39 months after GBP
• Results posted on: 2025-04-01

Participant Flow

126 consecutive patients were assessed on site (Gastrobese Clinic) between March and October 2007, 94 met the criteria. 8 patients were lost to follow-up, 4 before and 4 after GBP. Out of those, 15 were lost to follow-up and 18 refused to follow through, resulting on the actual 53 patients.

Participant milestones

Measure	Patients Assessed for GERD Patients assessed for GERD before and after Gastric Bypass Surgery
Before GBP STARTED	53
Before GBP COMPLETED	53
Before GBP NOT COMPLETED	0
6 Months After GBP STARTED	53
6 Months After GBP COMPLETED	53
6 Months After GBP NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

Baseline characteristics by cohort

Measure	Patients Assessed for GERD n=53 Participants Patients who had an open gastric bypass were assessed for GERD before and after surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.26 years STANDARD_DEVIATION 11.56 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment Brazil	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Before GBP, 6 months after GBP and 39 months after GBP

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.

Outcome measures

Measure	Before GBP n=53 Participants Patients assessed for GERD before Gastric Bypass Surgery	6 Months After GBP n=53 Participants Patients assessed for GERD 6 months after Gastric Bypass Surgery	39 Months After GBP n=53 Participants Patients assessed for GERD 39 months after Gastric Bypass Surgery
Number of Participants Presenting Reflux Symptoms	31 participants	8 participants	5 participants

PRIMARY outcome

Timeframe: Before GBP, 6 months after GBP and 39 months after GBP

Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis

Outcome measures

Measure	Before GBP n=53 Participants Patients assessed for GERD before Gastric Bypass Surgery	6 Months After GBP n=53 Participants Patients assessed for GERD 6 months after Gastric Bypass Surgery	39 Months After GBP n=53 Participants Patients assessed for GERD 39 months after Gastric Bypass Surgery
Number of Participants With Esophageal Injury	24 participants	17 participants	10 participants

PRIMARY outcome

Timeframe: Before GBP, 6 months after GBP and 39 months after GBP

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

Outcome measures

Measure	Before GBP n=53 Participants Patients assessed for GERD before Gastric Bypass Surgery	6 Months After GBP n=53 Participants Patients assessed for GERD 6 months after Gastric Bypass Surgery	39 Months After GBP n=53 Participants Patients assessed for GERD 39 months after Gastric Bypass Surgery
Number of Participants With Gastroesophageal Reflux Disease (GERD)	34 participants	21 participants	12 participants

PRIMARY outcome

Timeframe: Before GBP, 6 months after GBP and 39 months after GBP

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.

Outcome measures

Measure	Before GBP n=53 Participants Patients assessed for GERD before Gastric Bypass Surgery	6 Months After GBP n=53 Participants Patients assessed for GERD 6 months after Gastric Bypass Surgery	39 Months After GBP n=53 Participants Patients assessed for GERD 39 months after Gastric Bypass Surgery
Total Esophageal Acid Exposure at 24h pH Monitoring	5.1 percentage of time Interval 2.3 to 8.0	1.2 percentage of time Interval 0.3 to 6.3	0.1 percentage of time Interval 0.0 to 1.4

PRIMARY outcome

Timeframe: Before GBP, 6 months after GBP and 39 months after GBP

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

Outcome measures

Measure	Before GBP n=53 Participants Patients assessed for GERD before Gastric Bypass Surgery	6 Months After GBP n=53 Participants Patients assessed for GERD 6 months after Gastric Bypass Surgery	39 Months After GBP n=53 Participants Patients assessed for GERD 39 months after Gastric Bypass Surgery
Esophageal Acid Exposure at 24h pH Monitoring in Upright Position	5.9 percentage of time Interval 3.6 to 8.7	0.8 percentage of time Interval 0.2 to 2.7	0.1 percentage of time Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: Before GBP, 6 months after GBP and 39 months after GBP

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

Outcome measures

Measure	Before GBP n=53 Participants Patients assessed for GERD before Gastric Bypass Surgery	6 Months After GBP n=53 Participants Patients assessed for GERD 6 months after Gastric Bypass Surgery	39 Months After GBP n=53 Participants Patients assessed for GERD 39 months after Gastric Bypass Surgery
Esophageal Acid Exposure at 24h pH Monitoring in Supine Position	1.8 percentage of time Interval 0.1 to 6.3	0.5 percentage of time Interval 0.0 to 10.0	0.0 percentage of time Interval 0.0 to 0.4

PRIMARY outcome

Timeframe: Before GBP, 6 months after GBP and 39 months after GBP

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.

Outcome measures

Measure	Before GBP n=53 Participants Patients assessed for GERD before Gastric Bypass Surgery	6 Months After GBP n=53 Participants Patients assessed for GERD 6 months after Gastric Bypass Surgery	39 Months After GBP n=53 Participants Patients assessed for GERD 39 months after Gastric Bypass Surgery
Number of Participants With Increased Acid Exposure	31 participants	16 participants	9 participants

Adverse Events

Patients Assessed for GERD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carlos AS Madalosso, Director of Department of Metabolic and Bariatric Surgery

Clinica Gastrobese

Phone: +55(54)3045-4070

Email: madalosso@gastrobese.com.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place