Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux

Completed

• Conditions: Obesity; Gastroesophageal Reflux

• Registration Number: NCT02618044
• Lead Sponsor: University of Turin, Italy

Brief Summary

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available.

The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.

Detailed Description

Consecutive morbidly obese patients selected for LRYGB were included in a prospective study. The investigators performed clinical evaluation with GERD-HRQoL and GIS questionnaire, upper endoscopy, esophageal manometry and 24h-impedance pH monitoring (24h-MII-pH) preoperatively and at 12 and 60 months after surgery. Patients were divided into 2 groups according to the presence of GER at preoperative 24h-MII-pH.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2015-02
• Study Completion: 2015-07
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-26
• Status Verified: 2015-12
• Study First Posted: 2015-12-01
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• history of obesity exceeding 5 years
• documented previous weight loss attempts,
• body mass index (BMI)) of 40-50 kg/m2
• age of 18-60 years.

Exclusion Criteria

• contraindications to pneumoperitoneum
• large esophageal hiatal hernia
• pregnancy,
• drug or alcohol abuse,
• psychological disorders (e.g., bulimia, depression)
• hormonal or genetic obesity-related disease
• previous gastric surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of weakly acidic reflux	preoperatively, 12 and 60 months after LRYGB	number of weakly acidic reflux at 24 hour pH impedance monitoring

Secondary Outcome Measures

Name	Time	Method
Lower esophageal sphincter pressure	preoperatively, 12 and 60 months after LRYGB	Esophageal manometry measures lower esophageal sphincter pressure
GERD-HRQoL clinical score	preoperatively, 12 and 60 months after LRYGB	Standard and previous validated questionnaire was employed in the study to assess gastroesophageal function and quality of life
Amplitude of esophageal peristaltic waves	preoperatively, 12 and 60 months after LRYGB	Esophageal manometry evaluates amplitude of esophageal peristalsis
Grade of esophagitis	preoperatively, 12 and 60 months after LRYGB	Upper endoscopy is performed to assess the presence of esophagitis
Number of acidic reflux	preoperatively, 12 and 60 months after LRYGB	number of acidic reflux at 24 hour pH impedance monitoring