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NCT Number: NCT05611697

Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Vestfold, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single anastomosis sleeve ileal bypass

Procedure

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.

Other names: SASI

Sleeve gastrectomy

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. Change in prevalence of esophagitis.

    Time frame: 2 year

    Changes in the prevalence of esophagitis as evaluated by upper endoscopy.

  2. Change in prevalence of gastroesophageal reflux disease.

    Time frame: 2 year

    Changes in the prevalence of gastroesophageal reflux disease as evaluated by 24-hour pH measurements.

  3. Complications

    Time frame: 6 weeks (100 days for deaths), 2 year, 5 year

    Complications during surgery, postoperative complications (within 6 weeks [100 days for deaths]) as defined by the Accordion severity grading system and long-term complications.

  4. Obesity-related comorbid conditions.

    Time frame: 2 year, 5 year

    Changes in obesity-related comorbid conditions.

  5. Vitamin concentrations

    Time frame: 2 year, 5 year

    Changes in vitamin levels (A, B1, B6, B9, B12, C, D, K).

  6. Health-related quality of life

    Time frame: 2 year, 5 year

    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).

  7. Obesity-related symptoms

    Time frame: 2 year, 5 year

    Obesity-related Problem scale

  8. Gastrointestinal symptoms

    Time frame: 2 year, 5 year

    GSRS

  9. Gastroesophageal reflux disease symptoms

    Time frame: 2 year, 5 year

    GERDq

  10. Bowel habits

    Time frame: 2 year, 5 year

    Bowel habit questionnaire

  11. Revisional surgery

    Time frame: 2 year, 5 year

    Revisional surgery rates in the two groups.

  12. Long-term changes in BMI

    Time frame: 5 years

    BMI (weight in kilograms divided by the square of the height in meters) after sleeve gastrectomy and SASI.

  13. Body composition

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Helene M Haug, MD

CONTACT

[email protected]

+47 22 11 80 80

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial

Important dates

Study start
2023
Primary completion
2028
Study completion
2031
First posted
Nov 10, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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