Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Complications; Metabolic Syndrome; Obesity, Morbid; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: SASI Bipartition; Procedure: Gastric bypass

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Ebrahim Aghajani, PhD; Phone Number: +4798869107; Email: ebrahim.aghajani@aleris.no
• Study Contact Backup: Name: Carl Fredrik Schou, MD; Phone Number: +4792401527; Email: cfschou@online.no

Study Locations

• Norway
  • Oslo, Norway, 0264
    • Aleris Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SASI Bipartition; Subjects submitted to SASI Bipartition	Procedure: SASI Bipartition; 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
Roux-en-Y gastric bypass; Subjects submitted to gastric bypass	Procedure: Gastric bypass; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glycemia	Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l	before surgery up to 60 months after surgery
HbA1c	Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %	before surgery up to 60 months after surgery
Triglycerides	Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l	before surgery up to 60 months after surgery
Cholesterol	Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l	before surgery up to 60 months after surgery
HDL	Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l	before surgery up to 60 months after surgery
LDL	Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l	before surgery up to 60 months after surgery
Antidiabetic drugs	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.	3 to 60 months after surgery
Antilipidemic drugs	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.	3 to 60 months after surgery
Antihypertensive drugs	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.	3 to 60 months after surgery
Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA)	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.	3 to 60 months after surgery

Collaborators and Investigators

• Sponsor: Aleris Hospital
• Investigators: Principal Investigator: Ebrahim Aghajani, PhD, Aleris Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 11, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: GERD; Weight loss; Gastric Bypass,; SASI Bipartition; Internal Hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome; Obesity, Morbid; Postoperative Complications
• Other Study ID Numbers: 66095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The results of the study will be published in a scientific journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No