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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04469712
Other study ID # 66095
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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