Comparison of Two Surgical Techniques for Treatment of Type III Obesity (BMI 40-50 kg/m2): Single Anastomosis Duodenoileal Bypass With Sleeve Gastrectomy and Roux-en-Y Gastric Bypass.

NARecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2030

Conditions
Obesity
Interventions
PROCEDURE

SADI-S

In the case of SADI-S, the complete dissection of the antrum and the first portion of the duodenum is performed up to the limit of the gastroduodenal artery. The right gastric artery is dissected, clipped, and sectioned at its root. A vertical gastrectomy is created using a 38F Foucher tube with staplers. Next, the duodenum is sectioned with a stapler, and the resection of the greater gastric curvature is completed. Then, from the left side of the patient, 250 cm is measured from the ileocecal valve, where the duodenoileal anastomosis will be performed. This anastomosis is carried out with the surgeon positioned again between the patient's legs. A manual end-to-side anastomosis with two layers of monofilament is performed. Finally, the vertical gastrectomy and the duodenoileal anastomosis are verified using intraoperative endoscopy or a methylene blue and air test. The gastrectomy specimen is removed through the left pararectal trocar incision. A drain will only be placed in cases of s

PROCEDURE

RY-GBP

In the case of RY-GBP, first, the lesser gastric curvature is dissected between the cardia and the angular incisura, accessing the gastric transcavity. A horizontal gastric transection is performed using the first firing of a stapler. A gastric reservoir is created through successive firings with a 38F Foucher tube stapler. Next, 100 cm of the biliopancreatic limb is measured, where the manual or semi-mechanical gastrojejunostomy will be performed, with an end-to-side anastomosis using a stapler and manual closure of the loop. Then, 150 cm of the alimentary limb is measured, and a side-to-side jejunojejunostomy is created. A section is made between the two anastomoses. The mesenteric opening and the Petersen space are closed with a continuous non-absorbable suture. The anastomosis is verified using intraoperative endoscopy or a methylene blue and air test. A drain will only be placed in cases of special technical difficulty or intraoperative complications.

Trial Locations (1)

08036

RECRUITING

Hospital Clinic Barcelona, Barcelona

All Listed Sponsors
lead

Hospital Clinic of Barcelona

OTHER