Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)

NCT ID: NCT05948852

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2029-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A: SADI-S

SINGLE ANASTOMOSE DUODENAL SWITCH

Group Type EXPERIMENTAL

metabolic surgery (SADIS and OAGB)

Intervention Type PROCEDURE

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).

Group B: OAGB

SINGLE ANASTOMOSE GASTRIC BY-PASS

Group Type ACTIVE_COMPARATOR

metabolic surgery (SADIS and OAGB)

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari Integral

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sergio Sanchez Cordero, MD

Role: CONTACT

+34 93 553 12 00 ext. 8902

Other Identifiers

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23/001

Identifier Type: -

Identifier Source: org_study_id

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