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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TERMINATED
NA
124 participants
INTERVENTIONAL
2019-11-22
2025-05-28
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
SINGLE
Study Groups
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Crura Dissection
Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair.
Sleeve gastrectomy
Surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature.
Hiatal hernia repair
This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.
Crura dissection
The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.
National Practice
Participants with no detectable hiatal hernia will be randomized to either Group 2 or 3. Group 2 participants will be treated to the national practice patterns of complete dissection of the curvature of the stomach without dissection of the crura.
Sleeve gastrectomy
Surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature.
Standard of Care
Participants with no detectable hiatal hernia will be randomized to either Group 2 or 3. Group 3 participants will undergo the institutional standard of care with the dissection of the crura.
Sleeve gastrectomy
Surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature.
Crura dissection
The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.
Interventions
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Sleeve gastrectomy
Surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature.
Hiatal hernia repair
This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.
Crura dissection
The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.
Eligibility Criteria
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Inclusion Criteria
2. Age between 18-69 years
3. Able to provide consent
Exclusion Criteria
2. History of foregut surgery
3. Narcotic dependence
4. History of gastroparesis
5. Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study
18 Years
69 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Nestor De La Cruz-Munoz
Professor
Principal Investigators
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Nestor De La Cruz-Munoz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Medical Campus
Miami, Florida, United States
Countries
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Other Identifiers
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20190190
Identifier Type: -
Identifier Source: org_study_id
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