Clinical trial NCT05611697: Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity
Official title: Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Keywords: procedure: sleeve gastrectomy
bariatric surgery
procedure: single anastomosis sleeve ileal bypass
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized in a 1:1 ratio to sleeve gastrectomy or SASI. The randomization list will contain block sizes of 4 and 6 in random order, stratified by study center.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in body-mass index (BMI)
timeFrame: 2 year
Secondary outcomes:
measure: Change in prevalence of esophagitis.
timeFrame: 2 year
measure: Change in prevalence of gastroesophageal reflux disease.
timeFrame: 2 year
measure: Complications
timeFrame: 6 weeks (100 days for deaths), 2 year, 5 year
measure: Obesity-related comorbid conditions.
timeFrame: 2 year, 5 year
measure: Vitamin concentrations
timeFrame: 2 year, 5 year
measure: Health-related quality of life
timeFrame: 2 year, 5 year
measure: Obesity-related symptoms
timeFrame: 2 year, 5 year
measure: Gastrointestinal symptoms
timeFrame: 2 year, 5 year
measure: Gastroesophageal reflux disease symptoms
timeFrame: 2 year, 5 year
measure: Bowel habits
timeFrame: 2 year, 5 year
measure: Revisional surgery
timeFrame: 2 year, 5 year
measure: Long-term changes in BMI
timeFrame: 5 years
measure: Body composition
timeFrame: 2 years
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: The Morbid Obesity Center, Vestfold Hospital Trust
state: Vestfold
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Torgeir T Søvik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: