Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Small Bowel Obstruction
- Sponsor
- North-Western State Medical University named after I.I.Mechnikov
- Enrollment
- 180
- Locations
- 4
- Primary Endpoint
- Non-operative treatment success
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).
Detailed Description
Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.
Investigators
Kotkov Pavel
PhD, surgery department assistant
North-Western State Medical University named after I.I.Mechnikov
Eligibility Criteria
Inclusion Criteria
- •patients with acute intestinal obstruction
Exclusion Criteria
- •pregnancy;
- •peritonitis or strangulation, revealed during primary examination;
- •early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)
Outcomes
Primary Outcomes
Non-operative treatment success
Time Frame: 72 hours
Frequency of non-operative intestinal obstruction resolution
Secondary Outcomes
- Postoperative complications(up to 30 days)
- Overall mortality(up to 30 days)
- Resectional interventions(up to 30 days)