Crural Dissection in Sleeve Gastrectomy

Sleeve Gastrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04168060
• Other study ID #: 20190190
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami Medical Campus	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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