Crural Dissection in Sleeve Gastrectomy

University of Miami

Status: Terminated

Conditions: Sleeve Gastrectomy

Treatments: Procedure: Sleeve gastrectomy; Procedure: Hiatal hernia repair; Procedure: Crura dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT04168060

20190190

Details and patient eligibility

About

The purpose of this study is to identify if there is a benefit in routine dissection of the diaphragmatic crura during sleeve gastrectomy.

Enrollment: 124 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery
2. Age between 18-69 years
3. Able to provide consent

Exclusion criteria

1. History of anti-reflux procedure
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 3 patient groups

Crura Dissection

Experimental group

Description:

Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair.

Treatment:

Procedure: Crura dissection

Procedure: Hiatal hernia repair

Procedure: Sleeve gastrectomy

National Practice

Experimental group

Description:

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.

Treatment:

Procedure: Sleeve gastrectomy

Standard of Care

Experimental group

Description:

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.

Treatment:

Procedure: Crura dissection

Procedure: Sleeve gastrectomy