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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02692638
• Other study ID #: 1512016944
• Status: Terminated
• Phase: Phase 2
• Start date: February 2, 2016
• Est. completion date: October 13, 2016

Study information

• Verified date: February 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 13, 2016
• Est. primary completion date: October 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

Procedure:
• Early 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.
• nonoperative 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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications (per National Surgical Quality Improvement Project)	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)	2 weeks
Secondary	Average Length of stay	length, in days, of hospital stay, calculated by subtracting date of randomization from date of discharge	length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
Secondary	Average cost in dollars	average cost of care of patients per arm for length of hospital stay	length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
Secondary	number of subjects with hospital readmission		within 2 weeks of discharge
Secondary	number of subjects with unplanned return to operating room		within two weeks of discharge
Secondary	number of subjects with 30 day mortality		30 days post operation