Back to resultsLaparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity
Primary Purpose
Obesity, Morbid
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Single anastomosis sleeve ileal bypass
Sleeve gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring procedure: sleeve gastrectomy, bariatric surgery, procedure: single anastomosis sleeve ileal bypass
Eligibility Criteria
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.
Sites / Locations
- The Morbid Obesity Center, Vestfold Hospital Trust
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single anastomosis sleeve ileal bypass
Sleeve gastrectomy
Arm Description
A Single anastomosis sleeve ileal bypass procedure is performed.
A sleeve gastrectomy procedure is performed.
Outcomes
Primary Outcome Measures
Changes in body-mass index (BMI)
Weight in kilograms divided by the square of the height in meters after sleeve gastrectomy and SASI.
Secondary Outcome Measures
Change in prevalence of esophagitis.
Changes in the prevalence of esophagitis as evaluated by upper endoscopy.
Change in prevalence of gastroesophageal reflux disease.
Changes in the prevalence of gastroesophageal reflux disease as evaluated by 24-hour pH measurements.
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.
Obesity-related comorbid conditions.
Changes in obesity-related comorbid conditions.
Vitamin concentrations
Changes in vitamin levels (A, B1, B6, B9, B12, C, D, K).
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).
Obesity-related symptoms
Obesity-related Problem scale
Gastrointestinal symptoms
GSRS
Gastroesophageal reflux disease symptoms
GERDq
Bowel habits
Bowel habit questionnaire
Revisional surgery
Revisional surgery rates in the two groups.
Long-term changes in BMI
BMI (weight in kilograms divided by the square of the height in meters) after sleeve gastrectomy and SASI.
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.
Full Information
NCT ID
NCT05611697
First Posted
May 9, 2022
Last Updated
February 17, 2023
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05611697
Brief Title
Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity
Official Title
Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
procedure: sleeve gastrectomy, bariatric surgery, procedure: single anastomosis sleeve ileal bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Patients are allocated to surgical treatment 2 weeks before surgery and blinded to treatment allocation until the first postoperative day.
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single anastomosis sleeve ileal bypass
Arm Type
Experimental
Arm Description
A Single anastomosis sleeve ileal bypass procedure is performed.
Arm Title
Sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
A sleeve gastrectomy procedure is performed.
Intervention Type
Procedure
Intervention Name(s)
Single anastomosis sleeve ileal bypass
Other Intervention Name(s)
SASI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sleeve gastrectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in body-mass index (BMI)
Description
Weight in kilograms divided by the square of the height in meters after sleeve gastrectomy and SASI.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Change in prevalence of esophagitis.
Description
Changes in the prevalence of esophagitis as evaluated by upper endoscopy.
Time Frame
2 year
Title
Change in prevalence of gastroesophageal reflux disease.
Description
Changes in the prevalence of gastroesophageal reflux disease as evaluated by 24-hour pH measurements.
Time Frame
2 year
Title
Complications
Description
Complications during surgery, postoperative complications (within 6 weeks [100 days for deaths]) as defined by the Accordion severity grading system and long-term complications.
Time Frame
6 weeks (100 days for deaths), 2 year, 5 year
Title
Obesity-related comorbid conditions.
Description
Changes in obesity-related comorbid conditions.
Time Frame
2 year, 5 year
Title
Vitamin concentrations
Description
Changes in vitamin levels (A, B1, B6, B9, B12, C, D, K).
Time Frame
2 year, 5 year
Title
Health-related quality of life
Description
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).
Time Frame
2 year, 5 year
Title
Obesity-related symptoms
Description
Obesity-related Problem scale
Time Frame
2 year, 5 year
Title
Gastrointestinal symptoms
Description
GSRS
Time Frame
2 year, 5 year
Title
Gastroesophageal reflux disease symptoms
Description
GERDq
Time Frame
2 year, 5 year
Title
Bowel habits
Description
Bowel habit questionnaire
Time Frame
2 year, 5 year
Title
Revisional surgery
Description
Revisional surgery rates in the two groups.
Time Frame
2 year, 5 year
Title
Long-term changes in BMI
Description
BMI (weight in kilograms divided by the square of the height in meters) after sleeve gastrectomy and SASI.
Time Frame
5 years
Title
Body composition
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helene M Haug, MD
Phone
+47 22 11 80 80
Email
b31831@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torgeir T Søvik, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Morbid Obesity Center, Vestfold Hospital Trust
City
Tønsberg
State/Province
Vestfold
ZIP/Postal Code
3103
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marius Svanevik, MD, PhD
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
4950
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene M Haug, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity
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