Clinical trial NCT02692638: Trial Comparing Early Laparoscopic Enterolysis Versus Nonoperative Management for High-grade SBO
Official title: Prospective, Randomized Trial Comparing Early Laparoscopic Enterolysis Versus a Time-limited Trial of Nonoperative Management for High-grade Small Bowel Obstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small Bowel Obstruction
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of complications (per National Surgical Quality Improvement Project)
timeFrame: 2 weeks
Secondary outcomes:
measure: Average Length of stay
timeFrame: length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
measure: Average cost in dollars
timeFrame: length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
measure: number of subjects with hospital readmission
timeFrame: within 2 weeks of discharge
measure: number of subjects with unplanned return to operating room
timeFrame: within two weeks of discharge
measure: number of subjects with 30 day mortality
timeFrame: 30 days post operation
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Kevin Pei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Kimberly Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: