Prospective, Randomized Trial Comparing Early Laparoscopic Enterolysis Versus a Time-limited Trial of Nonoperative Management for High-grade Small Bowel Obstruction
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Yale University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of complications (per National Surgical Quality Improvement Project)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Early laparoscopic enterolysis
Patient randomized to the early laparoscopy arm will undergo diagnostic laparoscopy within 24 hours of admission (depending on surgeon and operating room availability). Standard laparoscopy will be performed including supine positioning, sequential compression devices, and appropriate pre-incision antibiotics. Trocar placement will be at the surgeon's discretion and as appropriate for the patient's previous incisions. The necessity for conversion will be left to the discretion of the attending surgeon. Post operative management will conform to the standards of care. Nasogastric tubes will not be routinely placed.
Intervention: Early laparoscopic enterolysis (Procedure)
trial of nonoperative management
Patients randomized to the trial of nonoperative management arm will undergo standard therapy including nil per os (NPO), nasogastric decompression only if actively vomiting, intravenous fluids while awaiting return of bowel function. Patients who do not achieve return of bowel function within 72 hours of admission will undergo attempted laparoscopic enterolysis with the understanding that conversion to open procedure may be necessary.
Intervention: nonoperative management (Procedure)
Outcomes
Primary Outcomes
Number of complications (per National Surgical Quality Improvement Project)
Time Frame: 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 Outcomes
- number of subjects with hospital readmission(within 2 weeks of discharge)
- number of subjects with unplanned return to operating room(within two 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.)
- Average cost in dollars(length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.)