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

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Yale University

Status and phase

Terminated
Phase 2

Conditions

Small Bowel Obstruction

Treatments

Procedure: Early laparoscopic enterolysis
Procedure: nonoperative management

Study type

Interventional

Funder types

Other

Identifiers

NCT02692638
1512016944

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3 participants in 2 patient groups

Early laparoscopic enterolysis
Experimental group
Description:
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.
Treatment:
Procedure: Early laparoscopic enterolysis
trial of nonoperative management
Active Comparator group
Description:
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.
Treatment:
Procedure: nonoperative management

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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