Obesity, MorbidNCT05611697
Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity
A study testing Single anastomosis sleeve ileal bypass and Sleeve gastrectomy in people with Obesity, Morbid, run by Oslo University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Single anastomosis sleeve ileal bypass and Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesNorway
- Study dates
- 17 Feb 2023to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Oslo University Hospital
Oslo, 4950
Helene M Haug, MD
- Recruiting
The Morbid Obesity Center, Vestfold Hospital Trust
Tønsberg, Vestfold, 3103
Marius Svanevik, MD, PhD
About this study
Official title: Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial
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.
Read the 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.
- Conditions
- Obesity, Morbid
- Being tested
- Single anastomosis sleeve ileal bypass, Sleeve gastrectomy
- Keywords
- procedure: sleeve gastrectomy, bariatric surgery, procedure: single anastomosis sleeve ileal bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single anastomosis sleeve ileal bypassProcedure or surgery
Also called SASI
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 gastrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single anastomosis sleeve ileal bypass | Experimental | A Single anastomosis sleeve ileal bypass procedure is performed. Receives: Procedure: Single anastomosis sleeve ileal bypass |
| Sleeve gastrectomy | Active comparator | A sleeve gastrectomy procedure is performed. Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body-mass index (BMI)
Weight in kilograms divided by the square of the height in meters after sleeve gastrectomy and SASI.
Measured: 2 year
Secondary outcomes (13)
Change in prevalence of esophagitis.
Changes in the prevalence of esophagitis as evaluated by upper endoscopy.
Measured: 2 year
Change in prevalence of gastroesophageal reflux disease.
Changes in the prevalence of gastroesophageal reflux disease as evaluated by 24-hour pH measurements.
Measured: 2 year
Complications
Complications during surgery, postoperative complications (within 6 weeks [100 days for deaths]) as defined by the Accordion severity grading system and long-term complications.
Measured: 6 weeks (100 days for deaths), 2 year, 5 year
Obesity-related comorbid conditions.
Changes in obesity-related comorbid conditions.
Measured: 2 year, 5 year
Vitamin concentrations
Changes in vitamin levels (A, B1, B6, B9, B12, C, D, K).
Measured: 2 year, 5 year
Health-related quality of life
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).
Measured: 2 year, 5 year
Obesity-related symptoms
Obesity-related Problem scale
Measured: 2 year, 5 year
Gastrointestinal symptoms
GSRS
Measured: 2 year, 5 year
Gastroesophageal reflux disease symptoms
GERDq
Measured: 2 year, 5 year
Bowel habits
Bowel habit questionnaire
Measured: 2 year, 5 year
Revisional surgery
Revisional surgery rates in the two groups.
Measured: 2 year, 5 year
Long-term changes in BMI
BMI (weight in kilograms divided by the square of the height in meters) after sleeve gastrectomy and SASI.
Measured: 5 years
Body composition
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start17 Feb 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torgeir Søvik, Oslo University Hospital
- Investigators
- Torgeir T Søvik, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611697
- Sponsor's protocol ID
- 319260
- Status last verified
- May 2026
- First submitted
- 9 May 2022
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05611697
- Acronym / sponsor ID
- 319260
- Conditions
- Obesity, Morbid
- Keywords
- procedure: sleeve gastrectomy, bariatric surgery, procedure: single anastomosis sleeve ileal bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single anastomosis sleeve ileal bypass | Experimental | Procedure: Single anastomosis sleeve ileal bypassA Single anastomosis sleeve ileal bypass procedure is performed. |
| Sleeve gastrectomy | Active comparator | Procedure: Sleeve gastrectomyA sleeve gastrectomy procedure is performed. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single anastomosis sleeve ileal bypassAlso: SASIThe 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. | Procedure or surgery | Single anastomosis sleeve ileal bypass |
| Sleeve gastrectomyIn 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. | Procedure or surgery | Sleeve gastrectomy |
Primary outcome
Changes in body-mass index (BMI)
Time frame: 2 year
Weight in kilograms divided by the square of the height in meters after sleeve gastrectomy and SASI.
13 secondary outcomes
Change in prevalence of esophagitis.
Time frame: 2 year
Change in prevalence of gastroesophageal reflux disease.
Time frame: 2 year
Complications
Time frame: 6 weeks (100 days for deaths), 2 year, 5 year
Obesity-related comorbid conditions.
Time frame: 2 year, 5 year
Vitamin concentrations
Time frame: 2 year, 5 year
Health-related quality of life
Time frame: 2 year, 5 year
Obesity-related symptoms
Time frame: 2 year, 5 year
Gastrointestinal symptoms
Time frame: 2 year, 5 year
Gastroesophageal reflux disease symptoms
Time frame: 2 year, 5 year
Bowel habits
Time frame: 2 year, 5 year
Revisional surgery
Time frame: 2 year, 5 year
Long-term changes in BMI
Time frame: 5 years
Body composition
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Torgeir T Søvik, MD, PhD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single anastomosis sleeve ileal bypass and Sleeve gastrectomy in people with Obesity, Morbid, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helene M Haug, MD (+47 22 11 80 80, b31831@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body-mass index (BMI) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.