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Active, Not Recruiting

NCT Number: NCT04469712

Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity, Morbid Bariatric Surgery Candidate Body Weight Body Weight Changes Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Glucose Metabolism Disorders Hernia Hyperinsulinism Insulin Resistance Internal Hernia Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aleris Hospital

Oslo, 0264, Norway

About this study

The Roux-en-Y Gastric Bypass (RYGB) is the procedure of choice in morbid obesity with metabolic disorders in most of the reference centers. Recent data describes the SASI Bipartition as being as efficient on weight loss and co-morbidities as the RYGB, with the advantage of being less technically difficult and less morbidity. In order to draw definite conclusions regarding the procedure, larger series with longer follow-up are necessary.

Patients with BMI over 40, or with BMI over 35 with comorbidities are offered SASI Bipartition with 300 cm common limb or standard RYGB. Follow up is performed through visits at 3, 12, 24, 36, 48, and 60 months after surgery.

Results on weight loss, comorbidities resolution, complications, and need of supplements are registered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis)

Exclusion criteria

  • Mental diseases
  • Drug addiction
  • Alcoholic
  • Malignancy
  • Pregnancy

Treatment and study plan

SASI Bipartition

Procedure

SASI Bipartition is performed with a sleeve gastrectomy over a 32 French gastric bougie and a 300 cm common limb. Side-to-side gastroileostomy with a diameter of approximately 2.5 cm at the anterior part of antrum, 6 cm proximal to pylorus.

Other names: Single-anastomosis Sleeve Ileal Bypass

Gastric bypass

Procedure

A small gastric pouch (15 mL) is created, and the jejunum brought up as an antecolic and antegastric fashion. Routine limb lengths were 150 cm for the alimentary limb and 60 cm for the bilio-pancreatic limb. Both mesenteric defects are closed with the Endohernia® stapler.

Other names: Roux-en-Y gastric bypass

Primary outcomes

  1. Weight change

    Time frame: 3 to 60 months after surgery

    Measured as percent of Excess Weight Loss (%EWL) using the following formula:

    ((weight at each study visit - initial weight) / (initial weight - ideal weight)) X 100

  2. Waist size change

    Time frame: 3 to 60 months after surgery

    Waist size (in cm)

  3. Medical and surgical complication

    Time frame: 3 to 60 months after surgery

    According to Clavien-Dindo classification

  4. Operative time

    Time frame: During surgery

    Expressed in minutes

  5. Hemoglobin

    Time frame: before surgery up to 60 months after surgery

    Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l

  6. Albumin

    Time frame: before surgery up to 60 months after surgery

    Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l

  7. Ferritin

    Time frame: before surgery up to 60 months after surgery

    Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l

  8. Iron

    Time frame: before surgery up to 60 months after surgery

    Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l

  9. Parathyroid hormone (PTH)

    Time frame: before surgery up to 60 months after surgery

    Measurement of PTH will explore the nutritional status of patients. Results will be expressed in pmol/L

  10. Vitamin B12

    Time frame: before surgery up to 60 months after surgery

    Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l

  11. Vitamin D

    Time frame: before surgery up to 60 months after surgery

    Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l

Secondary outcomes

  1. Fasting glycemia

    Time frame: before surgery up to 60 months after surgery

    Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

  2. HbA1c

    Time frame: before surgery up to 60 months after surgery

    Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %

  3. Triglycerides

    Time frame: before surgery up to 60 months after surgery

    Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l

  4. Cholesterol

    Time frame: before surgery up to 60 months after surgery

    Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

  5. HDL

    Time frame: before surgery up to 60 months after surgery

    Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

  6. LDL

    Time frame: before surgery up to 60 months after surgery

    Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

  7. Antidiabetic drugs

    Time frame: 3 to 60 months after surgery

    Evolution of antidiabetic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.

  8. Antilipidemic drugs

    Time frame: 3 to 60 months after surgery

    Evolution of antilipidemic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.

  9. Antihypertensive drugs

    Time frame: 3 to 60 months after surgery

    Evolution of antihypertensive drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.

  10. Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA)

    Time frame: 3 to 60 months after surgery

    Evolution of the use of Continuous Positive Airway Pressure will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of persistence or not of OSA.

Sponsors and collaborators

Lead sponsor

Aleris Hospital

Other

Registry information

Official study title

Long-term Outcomes of Bariatric Patients Treated With Gastric Bypass or Single-anastomosis Sleeve Ileal Bypass (SASI Bipartition)

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2020
Registry last updated
Feb 6, 2025

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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