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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05611697
Other study ID # 319260
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 17, 2023
Est. completion date December 2030

Study information

Verified date April 2024
Source Oslo University Hospital
Contact Helene M Haug, MD
Phone +47 22 11 80 80
Email b31831@ous-hf.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date December 2030
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Single anastomosis sleeve ileal bypass
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 gastrectomy
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-Stapleā„¢ 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.

Locations

Country Name City State
Norway Oslo University Hospital Oslo
Norway The Morbid Obesity Center, Vestfold Hospital Trust Tønsberg Vestfold

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in prevalence of esophagitis. Changes in the prevalence of esophagitis as evaluated by upper endoscopy. 2 year
Secondary Change in prevalence of gastroesophageal reflux disease. Changes in the prevalence of gastroesophageal reflux disease as evaluated by 24-hour pH measurements. 2 year
Secondary 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. 6 weeks (100 days for deaths), 2 year, 5 year
Secondary Obesity-related comorbid conditions. Changes in obesity-related comorbid conditions. 2 year, 5 year
Secondary Vitamin concentrations Changes in vitamin levels (A, B1, B6, B9, B12, C, D, K). 2 year, 5 year
Secondary 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). 2 year, 5 year
Secondary Obesity-related symptoms Obesity-related Problem scale 2 year, 5 year
Secondary Gastrointestinal symptoms GSRS 2 year, 5 year
Secondary Gastroesophageal reflux disease symptoms GERDq 2 year, 5 year
Secondary Bowel habits Bowel habit questionnaire 2 year, 5 year
Secondary Revisional surgery Revisional surgery rates in the two groups. 2 year, 5 year
Secondary Long-term changes in BMI BMI (weight in kilograms divided by the square of the height in meters) after sleeve gastrectomy and SASI. 5 years
Secondary 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. 2 years
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