Trial Comparing Early Laparoscopic Enterolysis Versus Nonoperative Management for High-grade SBO

Therapuetic Areas:Gastroenterology
Age Range:18 - Any
Start Date:April 2016
End Date:August 2019
Contact:Kevin Pei, MD

Use our guide to learn which trials are right for you!

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.

Inclusion Criteria:

- CT A/P showing high grade obstruction (all patients will obtain a CT A/P as per Level
1 recommendations based on EAST practice guidelines) .

- High grade bowel obstruction is defined as:

- Transition point

- Distal small collapse with proximal dilatation

- Small bowel feces sign

- 50% difference in caliber change between proximal dilated bowel and distal
decompressed bowel

- Intra-abdominal free fluid without clinical signs of ischemia

Exclusion Criteria:

- Hemodynamic instability (SBP<90)

- Peritonitis

- Enterocutaneous fistula

- Cirrhosis

- previous enterolysis (more than 1)

- Contraindication to laparoscopic surgery

- Pregnancy
We found this trial at
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Phone: 203-785-3942
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
New Haven, CT
Click here to add this to my saved trials