Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00951093

Enrollment

Registered

2009-08-04

Start date

2007-03-31

Completion date

2012-12-31

Last updated

2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease, Morbid Obesity

Keywords

GERD, Gastric bypass

Brief summary

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

Detailed 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.

Interventions

PROCEDUREGastric 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Morbid obesity * Acceptance to undergo open gastric bypass

Exclusion criteria

* Prior gastroesophageal surgery * Achalasia

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Presenting Reflux Symptoms	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.
Number of Participants With Esophageal Injury	Before GBP, 6 months after GBP and 39 months after GBP	Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis
Number of Participants With Gastroesophageal Reflux Disease (GERD)	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.
Total Esophageal Acid Exposure at 24h pH Monitoring	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.
Esophageal Acid Exposure at 24h pH Monitoring in Upright Position	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
Esophageal Acid Exposure at 24h pH Monitoring in Supine Position	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
Number of Participants With Increased Acid Exposure	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.

Countries

Brazil

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
Patients Assessed for GERD Patients who had an open gastric bypass were assessed for GERD before and after surgery.	53
Total	53

Baseline characteristics

Characteristic	Patients Assessed for GERD
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	53 Participants
Age, Continuous	38.26 years STANDARD_DEVIATION 11.56
Region of Enrollment Brazil	53 participants
Sex: Female, Male Female	38 Participants
Sex: Female, Male Male	15 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

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