Crural Dissection in Sleeve Gastrectomy

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Sleeve Gastrectomy
• Intervention / Treatment: Procedure: Crura dissection; Procedure: Sleeve gastrectomy; Procedure: Hiatal hernia repair

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: bariatric surgery; sleeve gastrectomy; crura dissection
• Other Study ID Numbers: 20190190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No