Obesity, MorbidOASISNCT05948852
Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)
A study testing metabolic surgery (SADIS and OAGB) in people with Obesity, Morbid, run by Consorci Sanitari Integral.
Trial summary
This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- metabolic surgery (SADIS and OAGB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2029
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 and under 65 who meet criteria for bariatric surgery.
- Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time
- Signature of the informed consent of the study
- Patients suitable for laparoscopic surgery
Who cannot join
- Previous bariatric surgery
- 2-stage surgery
- Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery
- Other associated surgical procedures in the same intervention.
- Conversion to laparotomy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sergio Sanchez Cordero, MD contact
About this study
Official title: Randomized Prospective Study Comparing Two Hypoabsorption Techniques for the Treatment of Type III Obesity (Body Mass Index Between 45 - 49.9 Kg/m2): Single Anastomose Duodenal Switch (SADI-S) and Single Anastomose Gastric By-pass (OAGBP)
This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.
- Conditions
- Obesity, Morbid
- Being tested
- metabolic surgery (SADIS and OAGB)
- Keywords
- OAGB, SADIS, bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolic surgery (SADIS and OAGB)Procedure or surgery
TWO HYPOABSORPTION TECHNIQUES FOR THE TREATMENT OF TYPE III OBESITY (BODY MASS INDEX BETWEEN 45 - 49.9 KG/M2): SINGLE ANASTOMOSE DUODENAL SWITCH (SADI-S) AND SINGLE ANASTOMOSE GASTRIC BY-PASS (OAGBP).
| Study group | Role | What they receive |
|---|---|---|
| Group A: SADI-S | Experimental | SINGLE ANASTOMOSE DUODENAL SWITCH Receives: Procedure: metabolic surgery (SADIS and OAGB) |
| Group B: OAGB | Active comparator | SINGLE ANASTOMOSE GASTRIC BY-PASS Receives: Procedure: metabolic surgery (SADIS and OAGB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of total weight loss (%TWL) of the patients after surgery
Measured: Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
Secondary outcomes (6)
% of patients with gastroesophageal reflux (acid and bile) after surgery
Measured: 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
Number of deaths in the immediate postoperative period
Measured: up to day 90 post-intervention
Number of Participants with complications in the immediate postoperative period
Measured: up to day 90 post-intervention
Ratio of patients with more than 3 loose stools per day
The ratio of patients with more than 3 loose stools per day will be evaluated as pathological. To assess the quality of the bowel movements, the Bristol Stool Form Scale questionnaire will be used. An evaluation of the number of bowel movements and their quality according to the Bristol Stool Form Scale questionnaire will be conducted at 1 year, 3 years, and 5 years after the surgery
Measured: 1 year, 3 years, 5 years after the surgery
questionnaire of quality of life
The quality of life will be assessed based on the results of the Moorehead-Ardelt II test and the Medical Outcomes Study Short Form-36 questionnaire. The Moorehead-Ardelt II questionnaire includes 6 parameters related to self-esteem, physical activity, social contact, job satisfaction, sexual pleasure, and eating habits. The minimum score is -3 and the maximum is +3. A score of 1.1 to 2 is considered a good result, and anything above 2.1 is considered very good.
The SF-36 questionnaire includes 8 parameters such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The minimum score is 0 and the maximum is 100.
Measured: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery
Number of patients with nutritional deficiencies
The main nutritional deficiencies to be evaluated after OAGB (One Anastomosis Gastric Bypass) and SADIS (Single Anastomosis Duodeno-Ileal Switch) are iron and/or vitamin B12 deficiency anemia, deficiencies in fat-soluble vitamins, calcium, and trace elements.
The incidence of nutritional deficiencies will be assessed through routine blood tests at 1 year, 3 years, and 5 years after the surgery
Measured: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948852
- Sponsor's protocol ID
- 23/001
- Acronym
- OASIS
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study Comparing Two Hypoabsorption Techniques for the Treatment of Type III Obesity (Body Mass Index Between 45 - 49.9 Kg/m2): Single Anastomose Duodenal Switch (SADI-S) and Single Anastomose Gastric By-pass (OAGBP)
- ClinicalTrials.gov ID
- NCT05948852
- Acronym / sponsor ID
- OASIS / 23/001
- Conditions
- Obesity, Morbid
- Keywords
- OAGB, SADIS, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: SADI-S | Experimental | Procedure: metabolic surgery (SADIS and OAGB)SINGLE ANASTOMOSE DUODENAL SWITCH |
| Group B: OAGB | Active comparator | Procedure: metabolic surgery (SADIS and OAGB)SINGLE ANASTOMOSE GASTRIC BY-PASS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 and under 65 who meet criteria for bariatric surgery.
- Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time
- Signature of the informed consent of the study
- Patients suitable for laparoscopic surgery
Key exclusion criteria (5 listed)
- Previous bariatric surgery
- 2-stage surgery
- Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery
- Other associated surgical procedures in the same intervention.
- Conversion to laparotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metabolic surgery (SADIS and OAGB)TWO HYPOABSORPTION TECHNIQUES FOR THE TREATMENT OF TYPE III OBESITY (BODY MASS INDEX BETWEEN 45 - 49.9 KG/M2): SINGLE ANASTOMOSE DUODENAL SWITCH (SADI-S) AND SINGLE ANASTOMOSE GASTRIC BY-PASS (OAGBP). | Procedure or surgery | Group A: SADI-S, Group B: OAGB |
Primary outcome
the percentage of total weight loss (%TWL) of the patients after surgery
Time frame: Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
6 secondary outcomes
% of patients with gastroesophageal reflux (acid and bile) after surgery
Time frame: 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
Number of deaths in the immediate postoperative period
Time frame: up to day 90 post-intervention
Number of Participants with complications in the immediate postoperative period
Time frame: up to day 90 post-intervention
Ratio of patients with more than 3 loose stools per day
Time frame: 1 year, 3 years, 5 years after the surgery
questionnaire of quality of life
Time frame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery
Number of patients with nutritional deficiencies
Time frame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergio Sanchez Cordero, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing metabolic surgery (SADIS and OAGB) in people with Obesity, Morbid, run by Consorci Sanitari Integral.
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 4 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: opening soon, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Sergio Sanchez Cordero, MD (+34 93 553 12 00 ext. 8902, Sergi.SanchezCordero@sanitatintegral.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of total weight loss (%TWL) of the patients after surgery (time frame: Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2023.