Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity
1 other identifier
interventional
220
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedStudy Start
First participant enrolled
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
April 3, 2024
April 1, 2024
4.8 years
May 9, 2022
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in body-mass index (BMI)
Weight in kilograms divided by the square of the height in meters after sleeve gastrectomy and SASI.
2 year
Secondary Outcomes (13)
Change in prevalence of esophagitis.
2 year
Change in prevalence of gastroesophageal reflux disease.
2 year
Complications
6 weeks (100 days for deaths), 2 year, 5 year
Obesity-related comorbid conditions.
2 year, 5 year
Vitamin concentrations
2 year, 5 year
- +8 more secondary outcomes
Study Arms (2)
Single anastomosis sleeve ileal bypass
EXPERIMENTALA Single anastomosis sleeve ileal bypass procedure is performed.
Sleeve gastrectomy
ACTIVE COMPARATORA sleeve gastrectomy procedure is performed.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Morbid Obesity Center, Vestfold Hospital Trust
Tønsberg, Vestfold, 3103, Norway
Oslo University Hospital
Oslo, 4950, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torgeir T Søvik, MD, PhD
Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients are allocated to surgical treatment 2 weeks before surgery and blinded to treatment allocation until the first postoperative day.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2022
First Posted
November 10, 2022
Study Start
February 17, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2030
Last Updated
April 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share