Small Bowel Obstruction
Conditions
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.
Interventions
PROCEDUREEarly laparoscopic enterolysis
The surgeon will make about 3-4 small incisions in the participant's abdomen. A port (nozzle) is inserted into one of the slits, and carbon dioxide gas inflates the abdomen. A laparoscope is inserted through another port. The laparoscope looks like a telescope with a light and camera on the end so the surgeon can see inside the abdomen. Surgical instruments are placed in the other small openings and used to cut the scar tissue in order to relieve the obstruction. After all this has been accomplished, the carbon dioxide is released out of the abdomen through the slits, and then these sites are closed with sutures or staples, or covered with glue-like bandage and steri-strips.
PROCEDUREnonoperative management
Sometimes a bowel obstruction can be treated by suctioning out the contents of the stomach, giving IV fluids, and not letting the patient eat for a few days.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Countries
United States
Outcome results
None listed