Crural Dissection in Sleeve Gastrectomy

University of Miami124 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

124

Conditions

Sleeve Gastrectomy

Interventions

Crura dissectionPROCEDURE

The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.

Sleeve gastrectomyPROCEDURE

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 repairPROCEDURE

This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami Medical Campus

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 12 months

Secondary Outcomes

Correlation of the presence of hiatal hernias

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

Time frame: Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.