Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-28 @ 7:05 PM
Study NCT ID:
NCT00951093
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2009-08-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass
Sponsor:
Clinica Gastrobese
Organization:
Study Overview
Official Title:
The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: