Sleeve Gastrectomy
Conditions
Keywords
sleeve gastrectomy, crura dissection, bariatric surgery
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.
Interventions
PROCEDURECrura dissection
The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.
PROCEDURESleeve 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.
PROCEDUREHiatal 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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed