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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Small Bowel Obstruction, Small Bowel Adhesion, Strangulation of Ileum

Intervention / Treatment
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* Procedure: Adhesiolysis
* Radiation: X-ray diagnostics
* Radiation: Computer tomography
* Procedure: Ultrasound
* Other: General and biochemical blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 80 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early surgery<br>After exclusion of indications for an emergency operation, conservative treatment is performed up to 12 hours from the moment of admission. Each patient receive blood test, blood lactate investigation, blood biochemistry, X-ray of the abdomen, ultrasound and CT on the admission. Each patient receive water-soluble contrast in 3 h after admission. In case of of clinical and radiologic signs of obstruction in 12 h after admission, surgery is performed. On the first stage of surgical treatment laparoscopic adhesiolysis is performed. If it is impossible to eliminate the cause of obstruction by laparoscopic technique laparotomy is performed. | Procedure: Adhesiolysis<br>* Method of video laparoscopic operation: Open access in the left upper quadrant of the anterior abdominal wall, Installation of trocars, depending on the prevalence of the adhesion process Assessment of the peritoneal adhesion index Detection of the asleep gut Detection of obstacle area Removing the obstacle without trying to completely eliminate the adhesion process in the abdominal cavity If there is no possibility to eliminate the cause of intestinal obstruction laparoscopically laparotomy is performed.<br>Radiation: X-ray diagnostics<br>* X-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast.<br>Radiation: Computer tomography<br>* Computer tomography of abdomen with iv contrast<br>Procedure: Ultrasound<br>* Ultrasound of the abdomen (2 times)<br>Other: General and biochemical blood test<br>* General blood test and biochemical blood test 2 times a day<br>|
| Active Comparator: Late surgery<br>After exclusion of indications for an emergency operation, conservative treatment is performed up to 48 hours from the moment of admission. Each patient receive blood test, blood lactate investigation, blood biochemistry, X-ray of the abdomen, ultrasound and CT on the admission. Each patient receive water-soluble contrast 3 h after admission. In case of present of obstruction and absence of contrast in colon in 36 h after intake (48 h after admission) a surgery is perform. On the first stage of surgical treatment laparoscopic adhesiolysis is performed. If it is impossible to eliminate the cause of obstruction by laparoscopic technique laparotomy is performed. | Procedure: Adhesiolysis<br>* Method of video laparoscopic operation: Open access in the left upper quadrant of the anterior abdominal wall, Installation of trocars, depending on the prevalence of the adhesion process Assessment of the peritoneal adhesion index Detection of the asleep gut Detection of obstacle area Removing the obstacle without trying to completely eliminate the adhesion process in the abdominal cavity If there is no possibility to eliminate the cause of intestinal obstruction laparoscopically laparotomy is performed.<br>Radiation: X-ray diagnostics<br>* X-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast.<br>Radiation: Computer tomography<br>* Computer tomography of abdomen with iv contrast<br>Procedure: Ultrasound<br>* Ultrasound of the abdomen (2 times)<br>Other: General and biochemical blood test<br>* General blood test and biochemical blood test 2 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of patients with obstruction release after conservative treatment | No of patients with success of conservative treatment | in the 2nd group - 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate in conservative treatment and surgery | 12 months readmission rate | 12 months | 
| 30 days mortality | Number of patients who has dead in 30 days after admission | 30 days | 
| Complications rate | Number of complications rate in groups | 30 days | 
| Quantity of bowel resection | Number of patients who undergo bowel resection in groups | 156 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conservative treatment, laparoscopic adhesiolysis, strangulation