Study Results
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-12-01
2026-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ileal Interposition
Interposition ileal surgery group Procedure/Surgery: Bariatric surgery
Ileal Interposition
Bariatric surgery by laparoscopic Ileal Interposition
Traditional surgical technique
Conventional revisional surgery group Procedure/Surgery: Bariatric surgery
Traditional surgical technique
Bariatric surgery by laparoscopic traditional technique
Interventions
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Ileal Interposition
Bariatric surgery by laparoscopic Ileal Interposition
Traditional surgical technique
Bariatric surgery by laparoscopic traditional technique
Eligibility Criteria
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Inclusion Criteria
* Loss of excess weight between 60 to 80%
* Rate of weight regain ≥60%
* Body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2, with at least 2 comorbidities associated with obesity
* Present a previous evaluation by the multidisciplinary team with a favorable opinion of the revision surgery.
Exclusion Criteria
* Severe psychotic or depressive disorder or history of suicide attempts in the last 12 months
* Eating behavior disorder (uncontrolled)
* Secondary causes of obesity
* Pregnancy
* Severe organ failure
* Active neoplastic
* Infectious or inflammatory disease
* Severe coagulopathy
* High anesthetic-surgical risk
* Intellectual inability
* Lack of preoperative follow-up
21 Years
60 Years
ALL
No
Sponsors
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Rio de Janeiro State University
OTHER
Responsible Party
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Luiz Guilherme Kraemer-Aguiar, MD
Principal Investigator
Principal Investigators
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Luiz Guilherme Kraemer-Aguiar, PhD
Role: PRINCIPAL_INVESTIGATOR
State University of Rio de Janeiro
Paulo Roberto G Falcão Leal, MD
Role: PRINCIPAL_INVESTIGATOR
State University of Rio de Janeiro
Karynne G Grutter Lopes, PhD
Role: PRINCIPAL_INVESTIGATOR
State University of Rio de Janeiro
Locations
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State University of Rio de Janeiro
Rio de Janeiro, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Luiz Guilherme Kraemer-Aguiar, PhD
Role: primary
Other Identifiers
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Ileal interposition
Identifier Type: -
Identifier Source: org_study_id
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