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

Stopped early · Phase 2

Conditions studied: Small Bowel Obstruction

In brief

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.

Key facts

Study ID

NCT02692638

Run by

Yale University

People needed

3

Starts

2016-02-02

Expected to finish

2016-10-13

Last updated by the study team

2020-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Hemodynamic instability (SBP<90)
• Peritonitis
• Enterocutaneous fistula
• Cirrhosis
• previous enterolysis (more than 1)
• Contraindication to laparoscopic surgery
• Pregnancy

Where it is running

• Yale New Haven Hospital — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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