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

Small Bowel Obstruction Clinical Trial

Official title: Prospective, Randomized Trial Comparing Early Laparoscopic Enterolysis Versus a Time-limited Trial of Nonoperative Management for High-grade Small Bowel Obstruction

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

• NCT number: NCT02692638
• Study type: Interventional
• Source: Yale University
• Status: Terminated
• Phase: Phase 2
• Start date: February 2, 2016
• Completion date: October 13, 2016