Comparing two surgical options for treating morbid obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of two bariatric surgical procedures: the single anastomosis sleeve ileal bypass (SASI) and sleeve gastrectomy. It aims to evaluate weight loss outcomes, gastroesophageal reflux, and the impact on obesity-related comorbidities in morbidly obese patients. The primary endpoint is the change in body mass index (BMI) over two years following the procedures. The SASI procedure is a newer approach that has been introduced in Norway, and this study seeks to determine its efficacy compared to the established sleeve gastrectomy.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Morbid Obesity Center, Vestfold Hospital Trust
  Tønsberg, Vestfold, Norway Recruiting
• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Torgeir T Søvik, MD, PhD — Oslo University Hospital
• Study coordinator: Helene M Haug, MD
• Email: b31831@ous-hf.no
• Phone: +47 22 11 80 80

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Glycemic variability after SASI versus Roux-en-Y gastric bypass

  This trial tests whether SASI or Roux-en-Y gastric bypass leads to different glucose fluctuations in adults with severe obesity using continuous glucose monitoring.

  Recruiting Hospitales Universitarios Virgen del Rocío · Seville, Sevilla · NCT07872397

• Postoperative nausea, vomiting and pain after bariatric surgery in Sweden

  This study looks at how often people have nausea, vomiting, and pain after bariatric surgery in Sweden and whether anesthesia type or regional blocks affect those outcomes.

  Recruiting at 2 sites Umeå University · Sundsvall and 1 other locations · NCT07797374

• Low-impact laparoscopy for sleeve gastrectomy in adults with obesity

  This will see if low-pressure, small-incision laparoscopy reduces post-surgery pain and improves breathing after sleeve gastrectomy in adults with obesity.

  Recruiting Fondazione Policlinico Universitario Campus Bio-Medico · Rome, Italy · NCT07119437

• Tranexamic acid to reduce bleeding in sleeve gastrectomy and mini gastric bypass

  This trial will test whether giving tranexamic acid before laparoscopic sleeve gastrectomy or mini gastric bypass reduces bleeding in adults with morbid obesity.

  Recruiting Phase 4 Patel Hospital, Pakistan · Karachi, Sindh · NCT07098780

• Predicting Quality of Life After Bariatric Surgery from Pre-Surgery Profiles

  This study tests whether pre-surgical patient traits can predict how quality of life changes after bariatric surgery for adults in the GEROM73 program.

  Recruiting Centre Hospitalier Metropole Savoie · Chambéry, Savoie · NCT06951893

• Endoscopic treatment for overweight and mild obesity using Orbera365

  This study is testing whether the Orbera365 intragastric balloon can help people who are overweight or mildly obese lose weight over a year.

  Recruiting Kaiser Clinic and Hospital · Santo André, São Paulo · NCT06785233

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.