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

Phase 2

Terminated

• Conditions: Small Bowel Obstruction

• Registration Number: NCT02692638
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2016-02-15
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Primary Completion: 2016-10-13
• Study Completion: 2016-10-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of complications (per National Surgical Quality Improvement Project)	2 weeks	complications counted : Superficial surgical site infection (SSI), Deep SSI, Organ space SSI, Wound disruption, pneumonia, Pulmonary embolism, ventilator days, Acute Kidney Injury (AKI), Acute renal failure (ARF), Urinary Tract Infection (UTI), Stroke, Cardiac arrest, Myocardial Infarction (MI), Sepsis, Deep vein thrombosis (DVT)

Secondary Outcome Measures

Name	Time	Method
number of subjects with unplanned return to operating room	within two weeks of discharge
number of subjects with hospital readmission	within 2 weeks of discharge
number of subjects with 30 day mortality	30 days post operation
Average Length of stay	length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.	length, in days, of hospital stay, calculated by subtracting date of randomization from date of discharge
Average cost in dollars	length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.	average cost of care of patients per arm for length of hospital stay

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States