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

University of Turin

Status: Completed

Conditions: Gastroesophageal Reflux; Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT02618044

WAROB/97

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

86 participants in 2 patient groups

Obese patients without preoperative GER

Description:

Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass without preoperative GER at 24h-impedance pH monitoring (Group G-)

Obese patients with preoperative GER

Description:

Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass with preoperative GER at 24h-impedance pH monitoring (Group G+)