Crural Dissection in Sleeve Gastrectomy

• ClinicalTrials.gov Identifier: NCT04168060
• Recruitment Status: Enrolling by invitation
• First Posted: November 19, 2019
• Last Update Posted: November 15, 2023
• Sponsor: University of Miami
• Information provided by (Responsible Party): Nestor De La Cruz-Munoz, University of Miami

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sleeve Gastrectomy	Procedure: Crura dissection; Procedure: Sleeve gastrectomy; Procedure: Hiatal hernia repair	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effect of Routine Crura Dissection in Sleeve Gastrectomy on Post-Operative Symptoms
• Actual Study Start Date: November 22, 2019
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Procedure: Crura dissection; The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.; Procedure: 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.; Procedure: 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.
Experimental: 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.	Procedure: 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.
Experimental: 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.	Procedure: Crura dissection; The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.; Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire [ Time Frame: Day 1, 12 months ]
   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.
2. Change in Perioperative Symptoms as assessed by the Rhodes Index of Nausea, Vomiting and Retching Questionnaire [ Time Frame: Day 1, 12 months ]
   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.
3. Change in Perioperative Symptoms as assessed by the Gastroesophageal Reflux Disease-Questionnaire (GERD-Q) [ Time Frame: Baseline, 12 months ]
   The GERD-Q has a scoring range between 0-18 with a higher score indicating increased likelihood of GERD.
4. Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ) [ Time Frame: Baseline, 12 months ]
   The BEDQ has a scoring range between 0-40 with a higher score indicating increased symptoms of dysphagia.

Secondary Outcome Measures :

1. Correlation of the presence of hiatal hernias [ Time Frame: Day 1 ]
   Correlation of the presence of hiatal hernias between pre-operative upper Gastrointestinal (GI) series and surgical findings.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

University of Miami Medical Campus

Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Investigators

• Principal Investigator: Nestor De La Cruz-Munoz, MD; University of Miami

More Information

• Responsible Party: Nestor De La Cruz-Munoz, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04168060
• Other Study ID Numbers: 20190190
• First Posted: November 19, 2019
• Last Update Posted: November 15, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nestor De La Cruz-Munoz, University of Miami:

sleeve gastrectomy; crura dissection; bariatric surgery