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Prospective, Randomized Trial Comparing Early Laparoscopic Enterolysis Versus a Time-limited Trial of Nonoperative Management for High-grade Small Bowel Obstruction
The goal is to assess the appropriateness of the standard practice of a trial of nonoperative management for high grade small bowel obstruction (currently up to 72 hours based on available literature). The investigator will offer early laparoscopic enterolysis (within 24 hours of admission) as the comparator group.
Small bowel obstruction is a common disorder without a clearly superior management strategy. There are an estimated 300,000 surgeries performed annually with a health care expenditure burden in excess of 2.8 billion dollars. The investigators propose a new management paradigm including early laparoscopic management. Contemporary management of SBO includes a trial of nonoperative management (TNOM) reportedly with resolution in upwards of 70% of patients. Although it is one of the most common diagnosis for surgical admissions, there are few prospective, clinical trials to address the question surgical timing. Additionally, there are no prospective, randomized trials comparing early laparoscopy versus TNOM for high grade SBO. The hypothesis is that early laparoscopic enterolysis will result in decreased overall complications, shorter length of stay, decreased health care cost, and lower conversion rate to open laparotomy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Yale New Haven Hospital
New Haven, Connecticut, United States
Start Date
February 2, 2016
Primary Completion Date
October 13, 2016
Completion Date
October 13, 2016
Last Updated
March 2, 2020
3
ACTUAL participants
Early laparoscopic enterolysis
PROCEDURE
nonoperative management
PROCEDURE
Lead Sponsor
Yale University
NCT05678023
NCT06065150
NCT07078981
Data Source & Attribution
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