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

Tracking Information

• First Submitted Date: November 15, 2019
• First Posted Date: November 19, 2019
• Last Update Posted Date: November 15, 2023
• Actual Study Start Date: November 22, 2019
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 15, 2019)

• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 15, 2019)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Crural Dissection in Sleeve Gastrectomy
• Official Title: The Effect of Routine Crura Dissection in Sleeve Gastrectomy on Post-Operative Symptoms
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Sleeve Gastrectomy

Intervention

• 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.

Study Arms

• 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.
  Interventions:

  • Procedure: Crura dissection
  • Procedure: Sleeve gastrectomy
  • Procedure: Hiatal hernia repair
• 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.
  Intervention: Procedure: Sleeve gastrectomy
• 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.
  Interventions:

  • Procedure: Crura dissection
  • Procedure: Sleeve gastrectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: November 15, 2019): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04168060
• Other Study ID Numbers: 20190190
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Nestor De La Cruz-Munoz, University of Miami
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Miami
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Miami
• Verification Date: November 2023