Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

February 5, 2025 updated by: Ebrahim Aghajani, Aleris Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway, 0264
        • Aleris Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: 3 to 60 months after surgery

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
Time Frame: 3 to 60 months after surgery
Waist size (in cm)
3 to 60 months after surgery
Medical and surgical complication
Time Frame: 3 to 60 months after surgery
According to Clavien-Dindo classification
3 to 60 months after surgery
Operative time
Time Frame: During surgery
Expressed in minutes
During surgery
Hemoglobin
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
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)
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting glycemia
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
before surgery up to 60 months after surgery
Triglycerides
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: before surgery up to 60 months after surgery
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
Time Frame: 3 to 60 months after surgery
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
Time Frame: 3 to 60 months after surgery
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
Time Frame: 3 to 60 months after surgery
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)
Time Frame: 3 to 60 months after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aleris Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ebrahim Aghajani, PhD, Aleris Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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