Crural Dissection in Sleeve Gastrectomy

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

Official Title
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The Effect of Routine Crura Dissection in Sleeve Gastrectomy on Post-Operative Symptoms

Conditions
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Sleeve Gastrectomy

Intervention / Treatment
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* Procedure: Crura dissection
* Procedure: Sleeve gastrectomy
* Procedure: Hiatal hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery Age between 18-69 years Able to provide consent Exclusion criteria: History of anti-reflux procedure History of foregut surgery Narcotic dependence History of gastroparesis Special/vulnerable populations such as minors, patients unable to consent, pregnant women, and prisoners will not be included in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crura Dissection<br>Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair. | Procedure: Crura dissection<br>* The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.<br>Procedure: Sleeve gastrectomy<br>* 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.<br>Procedure: Hiatal hernia repair<br>* This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.<br>|
| Experimental: National Practice<br>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. | Procedure: Sleeve gastrectomy<br>* 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.<br>|
| Experimental: Standard of Care<br>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. | Procedure: Crura dissection<br>* The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.<br>Procedure: Sleeve gastrectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire | The Intermediate and Late Post-Operative Pain, Nausea and Dysphagia Questionnaire is a 7-item questionnaire with scores ranging 0-40 with the higher score indicating severe symptoms. | Day 1, 12 months | 
| Change in Perioperative Symptoms as assessed by the Rhodes Index of Nausea, Vomiting and Retching Questionnaire | The Rhodes Index of Nausea, Vomiting and Retching Questionnaire is an 8-item questionnaire with scores ranging from 0 to 32 with a higher score indicating increased symptoms of nausea. | Day 1, 12 months | 
| Change in Perioperative Symptoms as assessed by the Gastroesophageal Reflux Disease-Questionnaire (GERD-Q) | The GERD-Q has a scoring range between 0-18 with a higher score indicating increased likelihood of GERD. | Baseline, 12 months | 
| Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ) | The BEDQ has a scoring range between 0-40 with a higher score indicating increased symptoms of dysphagia. | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the presence of hiatal hernias | Correlation of the presence of hiatal hernias between pre-operative upper Gastrointestinal (GI) series and surgical findings. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleeve gastrectomy, crura dissection, bariatric surgery