Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity
Recruiting · NCT05611697 · Interventional (participants receive a specific treatment) · Lead sponsor: Oslo University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Single anastomosis sleeve ileal bypassSleeve gastrectomy
What this trial 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.
Who can take part
Age range
20 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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).
- Age 20-60 years.
- Previous failed attempts of weight loss.
- Norwegian speaking patients.
Exclusion criteria
- BMI ≥55 kg/m2.
- A history of major abdominal or bariatric surgery (excluding appendectomy, cholecystectomy, and sectio).
- Established disabling cardiopulmonary disease, ongoing treatment for cancer, long-term steroid use, and conditions believed to be associated with poor adherence after surgery.
- 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.
- Achalasia
- Pregnancy.
Where it is running
2 locations listed.
- Oslo University Hospital - Oslo, Norway
- The Morbid Obesity Center, Vestfold Hospital Trust - Tønsberg, Vestfold, Norway