Low-osmolar Water Soluble Contrast Agent in Management of Adhesive Small Bowel Obstruction

Study Overview
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Brief Summary
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Adhesive small bowel obstruction (ASBO) is a condition that is commonly found in patients with history of abdominal surgery. The management for such condition can be controversial. In terms of conservative treatment, recent studies have shown conflicting outcomes on whether water soluble contrast would provide benefit in reducing number of patients needed for surgery. In addition, there are a limited number of literature that investigates the role of low-osmolar contrast in reducing operative need in patients diagnosed with ASBO. The objective of this study is to compare the operative rate of patient diagnosed with ASBO between patients who were treated with low osmolar water soluble contrast (Iohexol) and patients who were treated traditionally.

Detailed Description
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This study is a randomized, controlled and double-blinded study, where participants who were diagnosed with ASBO will be randomly allocated into two groups: (i) A contrast group (CG): Patients will be treated conservatively and received Omnipaque (Iohexol) via nasogastric tube (ii) A traditional group (TG): Patients will be treated conservatively and received sterile water via nasogastric tube After obtaining informed consent, the patient will be administered with either 100 mL of 350 mg Omnipaque or 100 mL of sterile water via nasogastric tube. The nasogastric tube will be clamped for 1 hour and patient will be positioned with 30 degree head elevation. In the contrast group (CG), surgery is indicated when contrast failed to reach the colon. Failure of conservative treatment is considered when there are no clinical improvements after 48 hours and the patient will then be proceeded for surgery.

Official Title
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Randomized Controlled Trial of Low-osmolar Water Soluble Contrast Agent in Management of Adhesive Small Bowel Obstruction

Conditions
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Small Bowel Adhesion, Small Bowel Obstruction

Intervention / Treatment
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* Procedure: Low osmolar contrast
* Procedure: Sterile water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are presented with clinical manifestation of small bowel obstruction due to adhesion and require radiological investigations Patients who has history of abdominal surgery over 30 days Exclusion Criteria: Patients with clinical signs and symptoms of bowel strangulation, ischemia, perforation or peritonitis Patients with clinical signs and symptoms of bowel obstruction from non-adhesive causes, including malignancy, herniation, inflammatory bowel disease, Crohn's disease, and others. Patients who has history of allergy to water soluble contrast agent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast group (CG)<br> | Procedure: Low osmolar contrast<br>* 100 mL of 350 mg omnipaque will be administered via nasogastric tube<br>|
| Active Comparator: Traditional group (TG)<br> | Procedure: Sterile water<br>* 100 mL of sterile water will be administered via nasogastric tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of operative intervention | Patients who developed signs of peritonitis or failed conservative treatment or no clinical improvement after 72 hours will be managed surgically | At 72 hour |