Crural Dissection in Sleeve Gastrectomy

Not Applicable

Terminated

• Conditions: Sleeve Gastrectomy

• 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: 2025-05
• Primary Completion: 2025-05-28
• Study Completion: 2025-05-28
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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