Clinical trial NCT04469712: Non-randomized Prospective Comparison Between SASI Bipartition and RYGB
Official title: Long-term Outcomes of Bariatric Patients Treated With Gastric Bypass or Single-anastomosis Sleeve Ileal Bypass (SASI Bipartition)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity, Morbid
Metabolic Syndrome
Bariatric Surgery Candidate
Postoperative Complications
Keywords: Gastric Bypass,
SASI Bipartition
Weight loss
GERD
Internal Hernia
Lead sponsor: Aleris Hospital
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients approved for bariatric surgery at Bariatric Clinic, Aleris Hospital, Norway

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight change
timeFrame: 3 to 60 months after surgery
measure: Waist size change
timeFrame: 3 to 60 months after surgery
measure: Medical and surgical complication
timeFrame: 3 to 60 months after surgery
measure: Operative time
timeFrame: During surgery
measure: Hemoglobin
timeFrame: before surgery up to 60 months after surgery
measure: Albumin
timeFrame: before surgery up to 60 months after surgery
measure: Ferritin
timeFrame: before surgery up to 60 months after surgery
measure: Iron
timeFrame: before surgery up to 60 months after surgery
measure: Parathyroid hormone (PTH)
timeFrame: before surgery up to 60 months after surgery
measure: Vitamin B12
timeFrame: before surgery up to 60 months after surgery
measure: Vitamin D
timeFrame: before surgery up to 60 months after surgery
Secondary outcomes:
measure: Fasting glycemia
timeFrame: before surgery up to 60 months after surgery
measure: HbA1c
timeFrame: before surgery up to 60 months after surgery
measure: Triglycerides
timeFrame: before surgery up to 60 months after surgery
measure: Cholesterol
timeFrame: before surgery up to 60 months after surgery
measure: HDL
timeFrame: before surgery up to 60 months after surgery
measure: LDL
timeFrame: before surgery up to 60 months after surgery
measure: Antidiabetic drugs
timeFrame: 3 to 60 months after surgery
measure: Antilipidemic drugs
timeFrame: 3 to 60 months after surgery
measure: Antihypertensive drugs
timeFrame: 3 to 60 months after surgery
measure: Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA)
timeFrame: 3 to 60 months after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Aleris Hospital
Study officials:
affiliation: Aleris Hospital
name: Ebrahim Aghajani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.