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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04168060
Other study ID # 20190190
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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