Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05611697

Recruiting nowNot applicableInterventional

What this study is about

This study will compare two bariatric surgical interventions in terms of weight loss, gastroesophageal reflux, and effects on obesity-related comorbid conditions in morbidly obese patients.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Morbid

Full registry criteria

Inclusion Criteria: 1. Morbid obesity at referral for bariatric surgery (i.e. a body-mass index \[BMI\] of ≥35 kg/m2 with obesity-related comorbid conditions or ≥40 kg/m2 with or without such comorbidities). 2. Age 20-60 years. 3. Previous failed attempts of weight loss. 4. Norwegian speaking patients. Exclusion Criteria: 1. BMI ≥55 kg/m2. 2. A history of major abdominal or bariatric surgery (excluding appendectomy, cholecystectomy, and sectio). 3. Established disabling cardiopulmonary disease, ongoing treatment for cancer, long-term steroid use, and conditions believed to be associated with poor adherence after surgery. 4. Previous or current gastroesophageal reflux symptoms with daily use of antireflux medication. Patients are also excluded if preoperative manometry identifies a hiatal hernia (≥4cm in axial length) or if preoperative upper endoscopy identifies esophagitis grade C or D (LA classification), peptic stricture, Barrett's esophagus, or esophageal carcinoma. 5. Achalasia 6. Pregnancy.

Treatments and study arms

Single anastomosis sleeve ileal bypass

Procedure

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.

Sleeve gastrectomy

Procedure

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.

Primary outcomes

Changes in body-mass index (BMI)2 year

Weight in kilograms divided by the square of the height in meters after sleeve gastrectomy and SASI.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Oslo University Hospital🇳🇴 Oslo, Norway

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Helene M Haug, MDContact

The Morbid Obesity Center, Vestfold Hospital Trust🇳🇴 Tønsberg, Vestfold, Norway

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Marius Svanevik, MD, PhDContact