Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction

Not Applicable

Recruiting

• Conditions: Small Bowel Obstruction; Small Bowel Adhesion
• Interventions: Procedure: Adhesiolysis; Radiation: X-ray examination; Procedure: Conservative treatment

• Registration Number: NCT05841069
• Lead Sponsor: North-Western State Medical University named after I.I.Mechnikov

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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short conservative treatment	X-ray examination	Conservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.
Short conservative treatment	Conservative treatment	Conservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.
Prolonged conservative treatment	Adhesiolysis	Conservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.
Prolonged conservative treatment	X-ray examination	Conservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.
Short conservative treatment	Adhesiolysis	Conservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.
Prolonged conservative treatment	Conservative treatment	Conservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.

Primary Outcome Measures

Name	Time	Method
Non-operative treatment success	72 hours	Frequency of non-operative intestinal obstruction resolution

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	up to 30 days	Number and variety of postoperative complications in patients, who underwent surgery
Overall mortality	up to 30 days	Number of patients, died during hospitalization
Resectional interventions	up to 30 days	Number of patients, who underwent surgery, including small bowel resection

Trial Locations

Locations (4)

26 City Hospital; 🇷🇺 Saint Petersburg, Russian Federation

North-Western State Medical University named after I. I. Mechnikov; 🇷🇺 Saint Petersburg, Russian Federation

Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine; 🇷🇺 Saint Petersburg, Russian Federation

The City Hospital of the Holy Martyr Elizabeth; 🇷🇺 Saint Petersburg, Russian Federation