Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity

NARecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

February 17, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2030

Conditions
Obesity, Morbid
Interventions
PROCEDURE

Single anastomosis sleeve ileal bypass

The abdominal cavity is entered directly (visual trocar) with or without the use of Verres needle. A 6-port set up and a liver retractor is utilized. A sleeve gastrectomy is performed as described below, but division of the stomach starts 6 cm proximal to the pylorus. The small bowel is measured 300cm from the ileocecal valve, with the small bowel stretched and markers placed on the graspers, and connected to the antrum of the stomach with a 45mm stapler. The anastomosis is positioned slightly ventral on the antrum. A 12 mm port positioned left to the midline is used for introduction of the stapler, which is directed distally from the patient's left to right side. 3.0 cm of 45 mm stapler is used the anastomosis; completed with a 2-0 PDS running suture. The biliopancreatic limb is anchored to the sleeve 4 cm proximal to the anastomosis (non-resorbable V-loc 3-0). Fascia defect is closed for the port where the specimen is extracted. The mesenteric defect is not closed.

PROCEDURE

Sleeve gastrectomy

In the laparoscopic sleeve gastrectomy, the abdominal cavity is entered directly with a visual trocar with or without the use of Verres needle. The set up includes a total of 5 ports. The Natanson liver retractor is utilized. The greater omentum is separated from the major side of the stomach from the pylorus to the angle of His. The left crus is visualized and the hiatus is inspected for the presence of hernia. A 36 French bougie is introduced and the stomach is divided along this from 4-5cm proximal to the pylorus to 1cm lateral to the angle of His using two purple cartridges (Medtronic Tri-Staple™ technology) followed by beige 60mm cartridges to the angle of His, 1 cm lateral to the esophagus. The sleeve is tested for leaks with instillation of 50ml methylene blue in the tube. The fascia defect is closed with suture for the port site where the specimen is extracted.

Trial Locations (2)

3103

NOT_YET_RECRUITING

The Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg

4950

RECRUITING

Oslo University Hospital, Oslo

All Listed Sponsors
lead

Oslo University Hospital

OTHER