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

Small Bowel Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06140173
• Other study ID #: 029/2565
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Queen Savang Vadhana Memorial Hospital, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Adhesion
• Small Bowel Obstruction

Intervention

Procedure:
• Low osmolar contrast
100 mL of 350 mg omnipaque will be administered via nasogastric tube
• Sterile water
100 mL of sterile water will be administered via nasogastric tube

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queen Savang Vadhana Memorial Hospital, Thailand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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