NCT06140173

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Small Bowel Adhesion
• Small Bowel Obstruction

Interventions

Type	Name	Description
PROCEDURE	Low osmolar contrast	100 mL of 350 mg omnipaque will be administered via nasogastric tube
PROCEDURE	Sterile water	100 mL of sterile water will be administered via nasogastric tube

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-04-01
• Completion: 2025-07-01
• First posted: 2023-11-18
• Last updated: 2024-04-04