Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04469712
• Other study ID #: 66095
• Status: Active, not recruiting
• Start date: August 1, 2020
• Est. completion date: August 1, 2027

Study information

• Verified date: August 2023
• Source: Aleris Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: August 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Aleris Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Aleris Hospital

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Waist size change	Waist size (in cm)	3 to 60 months after surgery
Primary	Medical and surgical complication	According to Clavien-Dindo classification	3 to 60 months after surgery
Primary	Operative time	Expressed in minutes	During surgery
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	HbA1c	Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %	before surgery up to 60 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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