Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

NCT04469712 | Active Not Recruiting

• 1 other identifier: 66095
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Morbid; Metabolic Syndrome; Bariatric Surgery Candidate; Postoperative Complications

Keywords

Gastric Bypass,; SASI Bipartition; Weight loss; GERD; Internal Hernia

Outcome Measures

Primary Outcomes (11)

• Weight change

  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

  3 to 60 months after surgery

• Waist size change

  Waist size (in cm)

  3 to 60 months after surgery

• Medical and surgical complication

  According to Clavien-Dindo classification

  3 to 60 months after surgery

• Operative time

  Expressed in minutes

  During surgery

• Hemoglobin

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

  before surgery up to 60 months after surgery

• Albumin

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

  before surgery up to 60 months after surgery

• Ferritin

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

  before surgery up to 60 months after surgery

• Iron

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

  before surgery up to 60 months after surgery

• Parathyroid hormone (PTH)

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

  before surgery up to 60 months after surgery

• Vitamin B12

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

  before surgery up to 60 months after surgery

• Vitamin D

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

  before surgery up to 60 months after surgery

Secondary Outcomes (10)

• Fasting glycemia

  before surgery up to 60 months after surgery

• HbA1c

  before surgery up to 60 months after surgery

• Triglycerides

  before surgery up to 60 months after surgery

• Cholesterol

  before surgery up to 60 months after surgery

• HDL

  before surgery up to 60 months after surgery

Study Arms (2)

SASI Bipartition

Subjects submitted to SASI Bipartition

Procedure: SASI Bipartition

Roux-en-Y gastric bypass

Subjects submitted to gastric bypass

Procedure: Gastric bypass

Interventions

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.

Also known as: Single-anastomosis Sleeve Ileal Bypass

SASI Bipartition

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.

Also known as: Roux-en-Y gastric bypass

Roux-en-Y gastric bypass

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients approved for bariatric surgery at Bariatric Clinic, Aleris Hospital, Norway

You may qualify if:

• \- 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)

You may not qualify if:

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

Sponsors & Collaborators

• Aleris Hospital: lead

Study Sites (1)

Aleris Hospital

Oslo, 0264, Norway

Location

Related Publications (5)

• Aghajani E, Nergaard BJ, Leifson BG, Hedenbro J, Gislason H. The mesenteric defects in laparoscopic Roux-en-Y gastric bypass: 5 years follow-up of non-closure versus closure using the stapler technique. Surg Endosc. 2017 Sep;31(9):3743-3748. doi: 10.1007/s00464-017-5415-2. Epub 2017 Feb 15.

  PMID: 28205037 BACKGROUND

• Santoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, Lacombe A, Santo MA. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012 Jul;256(1):104-10. doi: 10.1097/SLA.0b013e31825370c0.

  PMID: 22609843 BACKGROUND

• Mahdy T, Al Wahedi A, Schou C. Efficacy of single anastomosis sleeve ileal (SASI) bypass for type-2 diabetic morbid obese patients: Gastric bipartition, a novel metabolic surgery procedure: A retrospective cohort study. Int J Surg. 2016 Oct;34:28-34. doi: 10.1016/j.ijsu.2016.08.018. Epub 2016 Aug 19.

  PMID: 27545956 BACKGROUND

• Mui WL, Lee DW, Lam KK. Laparoscopic sleeve gastrectomy with loop bipartition: A novel metabolic operation in treating obese type II diabetes mellitus. Int J Surg Case Rep. 2014;5(2):56-8. doi: 10.1016/j.ijscr.2013.12.002. Epub 2013 Dec 10.

  PMID: 24441436 BACKGROUND

• Shah K, Johnny Nergard B, Stray Frazier K, Geir Leifsson B, Aghajani E, Gislason H. Long-term effects of laparoscopic Roux-en-Y gastric bypass on metabolic syndrome in patients with morbid obesity. Surg Obes Relat Dis. 2016 Sep-Oct;12(8):1449-1456. doi: 10.1016/j.soard.2016.03.017. Epub 2016 Mar 19.

  PMID: 27387692 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Obesity, Morbid; Metabolic Syndrome; Postoperative Complications; Weight Loss; Gastroesophageal Reflux; Internal Hernia

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes; Body Weight Changes; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Ebrahim Aghajani, PhD

  Aleris Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastrointestinal Surgeon, PhD, Principal investigator

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 14, 2020
• Study Start: August 1, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

NO (1)