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Clinical Trials/NCT03139149
NCT03139149
Recruiting
Not Applicable

Comparison of Early Operative Treatment (12 h) and 48 h Conservative Treatment in Acute Small Bowel Obstruction

Pirogov Russian National Research Medical University1 site in 1 country200 target enrollmentOctober 11, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Small Bowel Obstruction
Sponsor
Pirogov Russian National Research Medical University
Enrollment
200
Locations
1
Primary Endpoint
Quantity of patients with obstruction release after conservative treatment
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

This study will compare the results of early surgery after 12 h conservative treatment and 48 h conservative treatment of adhesive small bowel obstruction.

Detailed Description

At the admission patients undergo abdomen x-ray, general and biochemical blood test and computer tomography (CT). After exclusion of indications for an emergency operation, patients are given a water-soluble contrast. Conservative treatment is carring out to 12 hours from admission. All patients with resolution of small bowel obstruction in 12 hours will be excluded from the research. Criteria for obstruction release of conservative treatment 1. No pain 2. Appearance of gas in the colon 3. Decrease of bloating 4. Contrast in the colon. After that, if obstruction is not resolved, randomization is performed. First group undergo surgery. Second group undergo conservative treatment with water-soluble contrast evaluation until 48 hours. In the second group surgery is performed if the conservative treatment is not effective. The results of early and late surgery and the results of conservative treatment in groups will be compared.

Registry
clinicaltrials.gov
Start Date
October 11, 2017
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pirogov Russian National Research Medical University
Responsible Party
Principal Investigator
Principal Investigator

Alexander E. Tyagunov

MD. Prof

Pirogov Russian National Research Medical University

Eligibility Criteria

Inclusion Criteria

  • Patients with adhesive small bowel obstruction

Exclusion Criteria

  • Early postoperative small bowel obstruction Irreducible hernia Strangulation or peritonitis symptoms Impairment of consciousness Unstable hemodynamics

Outcomes

Primary Outcomes

Quantity of patients with obstruction release after conservative treatment

Time Frame: in the 2nd group - 48 hours

No of patients with success of conservative treatment

Secondary Outcomes

  • Readmission rate in conservative treatment and surgery(12 months)
  • 30 days mortality(30 days)
  • Complications rate(30 days)
  • Quantity of bowel resection(156 hours)

Study Sites (1)

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