Comparison of Early Operative Treatment and 48 h Conservative Treatment in Small Bowel Obstruction

Not Applicable

Recruiting

• Conditions: Small Bowel Adhesion; Small Bowel Obstruction; Strangulation of Ileum

• Registration Number: NCT03139149
• Lead Sponsor: Pirogov Russian National Research Medical University

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.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-03
• Study Start: 2017-10-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quantity of patients with obstruction release after conservative treatment	in the 2nd group - 48 hours	No of patients with success of conservative treatment

Secondary Outcome Measures

Name	Time	Method
Readmission rate in conservative treatment and surgery	12 months	12 months readmission rate
30 days mortality	30 days	Number of patients who has dead in 30 days after admission
Complications rate	30 days	Number of complications rate in groups
Quantity of bowel resection	156 hours	Number of patients who undergo bowel resection in groups

Trial Locations

Locations (1)

Moscow Clinical Hospital 1; 🇷🇺 Moscow, Russian Federation