An observational study in Gastroesophageal Reflux Disease and Morbid Obesity, sponsored by Clinica Gastrobese. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Clinica Gastrobese · Observational
The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 53 is below the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Clinica Gastrobese is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Primary care clinic patients
Exclusion Criteria:
Patients who had an open gastric bypass were assessed for GERD before and after surgery following the Montreal Consensus through a validated questionnaire in Portuguese language
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.
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.
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
Number of Participants With Esophageal Injury
Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
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.
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
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.
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
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
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
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
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
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.
Time frame: Before GBP, 6 months after GBP and 39 months after GBP
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.
| Milestone | Patients Assessed for GERD |
|---|---|
| Started | 53 |
| Completed | 53 |
| Not completed | 0 |
| Milestone | Patients Assessed for GERD |
|---|---|
| Started | 53 |
| Completed | 53 |
| Not completed | 0 |
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.
| participants | Before GBP | 6 Months After GBP | 39 Months After GBP |
|---|---|---|---|
| Number of Participants Presenting Reflux Symptoms | 31 | 8 | 5 |
Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis
| participants | Before GBP | 6 Months After GBP | 39 Months After GBP |
|---|---|---|---|
| Number of Participants With Esophageal Injury | 24 | 17 | 10 |
Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.
| participants | Before GBP | 6 Months After GBP | 39 Months After GBP |
|---|---|---|---|
| Number of Participants With Gastroesophageal Reflux Disease (GERD) | 34 | 21 | 12 |
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.
| percentage of time | Before GBP | 6 Months After GBP | 39 Months After GBP |
|---|---|---|---|
| Total Esophageal Acid Exposure at 24h pH Monitoring | 5.1 (2.3 to 8.0) | 1.2 (0.3 to 6.3) | 0.1 (0.0 to 1.4) |
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
| percentage of time | Before GBP | 6 Months After GBP | 39 Months After GBP |
|---|---|---|---|
| Esophageal Acid Exposure at 24h pH Monitoring in Upright Position | 5.9 (3.6 to 8.7) | 0.8 (0.2 to 2.7) | 0.1 (0.0 to 1.0) |
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
| percentage of time | Before GBP | 6 Months After GBP | 39 Months After GBP |
|---|---|---|---|
| Esophageal Acid Exposure at 24h pH Monitoring in Supine Position | 1.8 (0.1 to 6.3) | 0.5 (0 to 10) | 0.0 (0.0 to 0.4) |
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.
| participants | Before GBP | 6 Months After GBP | 39 Months After GBP |
|---|---|---|---|
| Number of Participants With Increased Acid Exposure | 31 | 16 | 9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Assessed for GERD | — | — | — |
Patients were enrolled irrespective of GERD symptoms according to the following criteria: 1. age between 18 and 70 years, 2. BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 combined with significant comorbidities, 3. absence of gastroesophageal surgery, and 4. consent to undergo open GBP
| Age, Categorical(Participants) | Patients Assessed for GERD |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 53 |
| >=65 years | 0 |
| Age, Continuous(years) | Patients Assessed for GERD |
|---|---|
| Mean | 38.26 ± 11.56 |
| Sex: Female, Male(Participants) | Patients Assessed for GERD |
|---|---|
| Female | 38 |
| Male | 15 |
| Region of Enrollment(participants) | Patients Assessed for GERD |
|---|---|
| Brazil | 53 |
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Clinica Gastrobese