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Obesity, MorbidNCT04469712

Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

An observational study of Obesity, Morbid and Metabolic Syndrome, run by Aleris Hospital at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
What is being tested?
SASI Bipartition and Gastric bypass
Type of treatment
Surgery or procedure
How many people
280 participants
Where
1 siteNorway
Study dates
1 Aug 2020to 1 Aug 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Aleris Hospital

    Oslo, 0264

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Being tested
SASI Bipartition, Gastric bypass
Keywords
Gastric Bypass,, SASI Bipartition, Weight loss, GERD, Internal Hernia
Medical subject headings
Obesity, Morbid, Metabolic Syndrome, Postoperative Complications, Weight Loss, Gastroesophageal Reflux, Internal Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SASI BipartitionProcedure or surgery

    Also called Single-anastomosis Sleeve Ileal Bypass

    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 bypassProcedure or surgery

    Also called Roux-en-Y 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.

Study groups in NCT04469712
Study groupRoleWhat they receive
SASI BipartitionSubjects submitted to SASI Bipartition
Receives: Procedure: SASI Bipartition
Roux-en-Y gastric bypassSubjects submitted to gastric bypass
Receives: Procedure: Gastric bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 to 60 months after surgery

  2. Waist size change

    Waist size (in cm)

    Measured: 3 to 60 months after surgery

  3. Medical and surgical complication

    According to Clavien-Dindo classification

    Measured: 3 to 60 months after surgery

  4. Operative time

    Expressed in minutes

    Measured: During surgery

  5. Hemoglobin

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

    Measured: before surgery up to 60 months after surgery

  6. Albumin

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

    Measured: before surgery up to 60 months after surgery

  7. Ferritin

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

    Measured: before surgery up to 60 months after surgery

  8. Iron

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

    Measured: before surgery up to 60 months after surgery

  9. Parathyroid hormone (PTH)

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

    Measured: before surgery up to 60 months after surgery

  10. Vitamin B12

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

    Measured: before surgery up to 60 months after surgery

  11. Vitamin D

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

    Measured: before surgery up to 60 months after surgery

Secondary outcomes (10)

  1. Fasting glycemia

    Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

    Measured: before surgery up to 60 months after surgery

  2. HbA1c

    Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %

    Measured: before surgery up to 60 months after surgery

  3. Triglycerides

    Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l

    Measured: before surgery up to 60 months after surgery

  4. Cholesterol

    Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

    Measured: before surgery up to 60 months after surgery

  5. HDL

    Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

    Measured: before surgery up to 60 months after surgery

  6. LDL

    Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

    Measured: before surgery up to 60 months after surgery

  7. 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.

    Measured: 3 to 60 months after surgery

  8. 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.

    Measured: 3 to 60 months after surgery

  9. 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.

    Measured: 3 to 60 months after surgery

  10. 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.

    Measured: 3 to 60 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
280 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04469712
Sponsor's protocol ID
66095
Status last verified
Feb 2025
First submitted
3 Jul 2020
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The results of the study will be published in a scientific journal.

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.

    PubMed 28205037

  • 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.

    PubMed 22609843

  • 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.

    PubMed 27545956

  • 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.

    PubMed 24441436

  • 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.

    PubMed 27387692

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Morbid and Metabolic Syndrome, run by Aleris Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight change (time frame: 3 to 60 months after surgery). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469712, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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