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

Not Applicable

Recruiting

• Conditions: Obesity, Morbid
• Interventions: Procedure: Single anastomosis sleeve ileal bypass; Procedure: Sleeve gastrectomy

• Registration Number: NCT05611697
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Sleeve gastrectomy is an established therapeutic option for morbidly obese patients without preexisting gastroesophageal reflux disease. The novel single anastomosis sleeve ileal bypass (SASI) procedure is already introduced in Norway at a private high-volume bariatric hospital. The purpose of this study is to evaluate the effects of SASI in comparison to an established bariatric procedure, i.e. sleeve gastrectomy. The primary end point is 2-year changes in BMI after sleeve gastrectomy and SASI.

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Study Start: 2023-02-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2027-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single anastomosis sleeve ileal bypass	Single anastomosis sleeve ileal bypass	A Single anastomosis sleeve ileal bypass procedure is performed.
Sleeve gastrectomy	Sleeve gastrectomy	A sleeve gastrectomy procedure is performed.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change in prevalence of esophagitis.	2 year	Changes in the prevalence of esophagitis as evaluated by upper endoscopy.
Change in prevalence of gastroesophageal reflux disease.	2 year	Changes in the prevalence of gastroesophageal reflux disease as evaluated by 24-hour pH measurements.
Complications	6 weeks (100 days for deaths), 2 year, 5 year	Complications during surgery, postoperative complications (within 6 weeks \[100 days for deaths\]) as defined by the Accordion severity grading system and long-term complications.
Obesity-related comorbid conditions.	2 year, 5 year	Changes in obesity-related comorbid conditions.
Vitamin concentrations	2 year, 5 year	Changes in vitamin levels (A, B1, B6, B9, B12, C, D, K).
Gastrointestinal symptoms	2 year, 5 year	GSRS
Revisional surgery	2 year, 5 year	Revisional surgery rates in the two groups.
Health-related quality of life	2 year, 5 year	The RAND 36-Item Short Form Health Survery is a self-reporting questionnaire. Items are scored from 0 (lowest score) to 100 (highest possible score).
Obesity-related symptoms	2 year, 5 year	Obesity-related Problem scale
Gastroesophageal reflux disease symptoms	2 year, 5 year	GERDq
Bowel habits	2 year, 5 year	Bowel habit questionnaire
Long-term changes in BMI	5 years	BMI (weight in kilograms divided by the square of the height in meters) after sleeve gastrectomy and SASI.
Body composition	2 years	Changes in percentage fat mass and lean mass; percentage change in bone mineral density in lumbar spine (L1-L4), femoral neck, and total hip as assessed by DEXA scan.

Trial Locations

Locations (2)

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

Oslo University Hospital; 🇳🇴 Oslo, Norway