Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)
OASIS
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)
1 other identifier
interventional
96
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
ExpectedJuly 17, 2023
July 1, 2023
1 year
June 12, 2023
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the percentage of total weight loss (%TWL) of the patients after surgery
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
1 year, 3 year, 5 year after SADI-S and OAGBP surgery
Number of deaths in the immediate postoperative period
up to day 90 post-intervention
Number of Participants with complications in the immediate postoperative period
up to day 90 post-intervention
Ratio of patients with more than 3 loose stools per day
1 year, 3 years, 5 years after the surgery
questionnaire of quality of life
1 year, 3 years, 5 years after SADI-S and OAGBP surgery
- +1 more secondary outcomes
Study Arms (2)
Group A: SADI-S
EXPERIMENTALSINGLE ANASTOMOSE DUODENAL SWITCH
Group B: OAGB
ACTIVE COMPARATORSINGLE ANASTOMOSE GASTRIC BY-PASS
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous bariatric surgery
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2023
First Posted
July 17, 2023
Study Start
July 1, 2023
Primary Completion
July 1, 2024
Study Completion (Estimated)
July 1, 2029
Last Updated
July 17, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share