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Procedure

Crural Dissection for Sleeve Gastrectomy

N/A
Waitlist Available
Led By Nestor De La Cruz-Munoz, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients undergoing primary sleeve gastrectomy at the University of Miami Division of Bariatric surgery
Age between 18-69 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months
Awards & highlights

Study Summary

This trial will help surgeons understand if they should routinely dissect the diaphragmatic crura during sleeve gastrectomy.

Who is the study for?
This trial is for adults aged 18-69 planning to undergo primary sleeve gastrectomy at the University of Miami's Bariatric surgery division. It excludes those with a history of anti-reflux procedures, foregut surgeries, gastroparesis, narcotic dependence, and vulnerable groups unable to consent.Check my eligibility
What is being tested?
The study aims to determine if routinely dissecting the diaphragmatic crura during a sleeve gastrectomy (a weight-loss surgery) offers any benefits. This includes patients who may also require hiatal hernia repair.See study design
What are the potential side effects?
While not explicitly stated in this summary, potential side effects could include typical surgical risks such as pain, infection at the incision site, bleeding, and possible complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having a sleeve gastrectomy at the University of Miami.
Select...
I am between 18 and 69 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Perioperative Symptoms as assessed by the Brief Esophageal Dysphagia Questionnaire (BEDQ)
Change in Perioperative Symptoms as assessed by the Gastroesophageal Reflux Disease-Questionnaire (GERD-Q)
Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire
+1 more
Secondary outcome measures
Correlation of the presence of hiatal hernias

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment2 Interventions
Participants with no detectable hiatal hernia will be randomized to either Group 2 or 3. Group 3 participants will undergo the institutional standard of care with the dissection of the crura.
Group II: National PracticeExperimental Treatment1 Intervention
Participants with no detectable hiatal hernia will be randomized to either Group 2 or 3. Group 2 participants will be treated to the national practice patterns of complete dissection of the curvature of the stomach without dissection of the crura.
Group III: Crura DissectionExperimental Treatment3 Interventions
Participants with a visually detectable hiatal hernia at the time of sleeve gastrectomy procedure will undergo a crura dissection and hiatal hernia repair.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleeve gastrectomy
2013
Completed Phase 3
~11150

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
899 Previous Clinical Trials
409,482 Total Patients Enrolled
Nestor De La Cruz-Munoz, MDPrincipal InvestigatorUniversity of Miami

Media Library

Sleeve Gastrectomy Research Study Groups: Standard of Care, National Practice, Crura Dissection
Sleeve Gastrectomy Clinical Trial 2023: Sleeve gastrectomy Highlights & Side Effects. Trial Name: NCT04168060 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become a participant in this research?

"Eligible participants for this trial must be between 18-69 years old, have had a sleeve gastrectomy, and meet the other requirements which are listed on the website."

Answered by AI

Are there any positions still available for participants in this experiment?

"Unfortunately, this clinical trial is not presently recruiting patients. Although the study was last updated on April 14th, 2022, it originally posted on November 22nd, 2019. There are other 7 trials enrolling patients at the moment though."

Answered by AI

If an eligible person is below the age of 55, can they participate in this research?

"According to the eligibility requirements listed for this trial, the age of potential participants must be between 18 and 69."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
University of Miami Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Crural Dissection in Sleeve Gastrectomy
Nestor De La Cruz-Munoz 2019. "Crural Dissection in Sleeve Gastrectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04168060.
~33 spots leftby Dec 2024
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