Sleeve gastrectomy for Sleeve Gastrectomy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sleeve Gastrectomy
Sleeve gastrectomy - Procedure
Eligibility
18+
All Sexes
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 1 Secondary · Reporting Duration: Baseline, 12 months

Baseline, 12 months
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)
Day 1
Correlation of the presence of hiatal hernias
Day 1, 12 months
Change in Perioperative Symptoms as assessed by the Intermediate and Late-Post Operative Pain, Nausea and Dysphagia Questionnaire
Change in Perioperative Symptoms as assessed by the Rhodes Index of Nausea, Vomiting and Retching Questionnaire

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Standard of Care
1 of 3
National Practice
1 of 3
Crura Dissection
1 of 3
Experimental Treatment

250 Total Participants · 3 Treatment Groups

Primary Treatment: Sleeve gastrectomy · No Placebo Group · N/A

Standard of CareExperimental Group · 2 Interventions: Sleeve gastrectomy, Crura dissection · Intervention Types: Procedure, Procedure
National Practice
Procedure
Experimental Group · 1 Intervention: Sleeve gastrectomy · Intervention Types: Procedure
Crura DissectionExperimental Group · 3 Interventions: Sleeve gastrectomy, Hiatal hernia repair, Crura dissection · Intervention Types: Procedure, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleeve gastrectomy
2013
Completed Phase 3
~11000

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 12 months

Who is running the clinical trial?

University of MiamiLead Sponsor
787 Previous Clinical Trials
384,160 Total Patients Enrolled
Nestor De La Cruz-Munoz, MDPrincipal InvestigatorUniversity of Miami

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The ability to provide consent is an important aspect of human autonomy
will be offered a comprehensive postoperative care program that includes nutritional guidance, psychological support, and physical rehabilitation
old People aged between 18-69 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Miami Medical Campus100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%