NCT07537244

Impact of GEA Simultaneous to VSG on Post-operative GERD

Impact of Gastroenteroanastomosis Simultaneous to Vertical Gastrectomy on Post-operative Gastroesophageal Reflux

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Clinica Gastrobese · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effect of GEA on GERD in patients undergoing VSG. The main question it aims to answer is: • Does adoption of GEA to VSG reduce the occurrence of GERD? Participants will complete a symptom questionnaire during follow-up visits. All exams are already part of the surgical or GERD follow-up routine. Researchers will compare with GEA (Group A) and Without GEA (Group B) to see if adopting GEA during VSG reduces the occurrence of GERD.

Detailed description

All patients aged between 18 and 65 years old who are candidates for bariatric surgery, who opt for VSG, will be consecutively invited to participate in the open study. Initially, patients will be allocated into two groups, matched by BMI and age. Regarding age, they will be separated into two categories: between 18 and 40 years old, ≥40 years old. Regarding BMI, they will be divided into two groups: BMI\<40 and BMI≥40. After being allocated according to weight criteria, the randomization for the GEA will proceed through a draw during the surgical procedure, after making the gastric tube. So, we will have two groups: With GEA (Group A); and Without GEA (Group B), both with 30 patients each, totaling 60 research participants. All patients will be evaluated for GERD before, 12, 24 and 60 months after surgery, and will have permanent access to the team regarding the details of their operations that may be necessary.

Conditions

• Obesity
• Reflux, Gastroesophageal

Interventions

Type	Name	Description
PROCEDURE	gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy	GEA will be held after completion of GV. The small intestine is then measured every 5 cm, measured with the aid of markings on the laparoscopic clamps, and at 280 cm the manual laterolateral gastroileal anastomosis is performed between 4 and 5 cm in an isoperistaltic direction and 3 cm proximally to the pylorus. Then, 40 cm distally to the gastroileoanastomosis, the Roux-en-Y is constructed with a 2-cm diameter lateral-to-side manual anastomosis followed by the transection of the ileal limb segment interposed with the anastomoses.
PROCEDURE	vertical sleeve gastrectomy	VSG will be performed as primary surgery. The greater curvature is released up to the angle of His in order to perform an ascending stapling from 5 cm proximal to the pylorus to 1 cm from the angle of His and guided by a 32 French Fouchet probe. Stapling starts 5 cm from the pylorus and extends to 1 cm from the angle of His. The result is a tube of approximately 150 ml as adapted in consensus.

Timeline

• Start date: 2023-02-18
• Primary completion: 2024-03-04
• Completion: 2028-04-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Brazil