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

Long Term Effects of Laparoscopic Roux-en-Y Gastric Bypass on Gastro-esophageal Reflux: Clinical Impact of Weakly Acidic Reflux

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02618044

Enrollment

Registered

2015-12-01

Start date

2006-05-31

Completion date

2015-07-31

Last updated

2015-12-03

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

Conditions

Gastroesophageal Reflux, Obesity

Keywords

Gastroesophageal reflux, Obesity, Esophageal manometry, 24 H impedance pH-monitoring, Laparoscopic Roux-en-Y Gastric Bypass

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Lower esophageal sphincter pressure	preoperatively, 12 and 60 months after LRYGB	Esophageal manometry measures lower esophageal sphincter pressure
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

Outcome results