Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction

Conditions
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Small Bowel Obstruction, Small Bowel Adhesion

Intervention / Treatment
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* Procedure: Adhesiolysis
* Radiation: X-ray examination
* Procedure: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter controlled randomized prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short conservative treatment<br>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. | Procedure: Adhesiolysis<br>* Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.<br>Radiation: X-ray examination<br>* Plain X-ray of abdomen (1-4 times) with water insoluble contrast.<br>Procedure: Conservative treatment<br>* A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.<br>|
| Experimental: Prolonged conservative treatment<br>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. | Procedure: Adhesiolysis<br>* Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.<br>Radiation: X-ray examination<br>* Plain X-ray of abdomen (1-4 times) with water insoluble contrast.<br>Procedure: Conservative treatment<br>* A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-operative treatment success | Frequency of non-operative intestinal obstruction resolution | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | Number of patients, died during hospitalization | up to 30 days | 
| Postoperative complications | Number and variety of postoperative complications in patients, who underwent surgery | up to 30 days | 
| Resectional interventions | Number of patients, who underwent surgery, including small bowel resection | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute adhesive intestinal obstruction, conservative treatment