Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP

Clinica Gastrobese

Status: Terminated

Conditions: Vomiting; Gastroesophageal Reflux Disease; Morbid Obesity

Treatments: Procedure: Sham Comparator: no ring; Procedure: RYGBP-RING

Study type: Interventional

Funder types: Other

Identifiers

NCT01212835

GASTROBESE 005

Details and patient eligibility

About

Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.

Full description

This is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or GERD symptoms.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 58 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indications for bariatric surgery (BMI over 40Kg/m2 or over 35Kg/m2 associated to a life-treating morbid conditions.
• Acceptance to be submitted to a 24h pH-monitoring and esophageal manometry
• No contra-indication for gastric bypass
• Absence of previous gastric surgery
• Option for open gastric bypass

Exclusion criteria

• Inferior and superior total teeth prosthesis
• Poor surgical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

114 participants in 2 patient groups

no ring

Sham Comparator group

Description:

Patients at this group will have RING REMOVED AT THE END OF SURGERY.

Treatment:

Procedure: Sham Comparator: no ring

RYGBP-Ring

Active Comparator group

Description:

Open Roux-en-Y gastric bypass with a silastic ring which is performed with linear cut stapler 100 mm and a biliopancreatic limb of 60 cm long and a alimentary limb of 100 cm long. All patients will have a 6.5 cm silastic ring located at the middle of the pouch above of the gastroenteroanastomosis.

Treatment:

Procedure: RYGBP-RING