Crural Dissection in Sleeve Gastrectomy

Not Applicable

• Conditions: Sleeve Gastrectomy
• Interventions: Procedure: Crura dissection; Procedure: Sleeve gastrectomy; Procedure: Hiatal hernia repair

• Registration Number: NCT04168060
• Lead Sponsor: University of Miami

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 available

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Study Start: 2019-11-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crura Dissection	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.
Crura Dissection	Hiatal hernia repair	Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair.
National Practice	Sleeve gastrectomy	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.
Crura Dissection	Sleeve gastrectomy	Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair.
Standard of Care	Crura dissection	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.
Standard of Care	Sleeve gastrectomy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation of the presence of hiatal hernias	Day 1	Correlation of the presence of hiatal hernias between pre-operative upper Gastrointestinal (GI) series and surgical findings.

Trial Locations

Locations (1)

University of Miami Medical Campus; 🇺🇸 Miami, Florida, United States