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

NCT06140173 | Not Yet Recruiting

• 1 other identifier: 029/2565
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Small Bowel Adhesion; Small Bowel Obstruction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Contrast group (CG)

EXPERIMENTAL

Procedure: Low osmolar contrast

Traditional group (TG)

ACTIVE COMPARATOR

Procedure: Sterile water

Interventions

Low osmolar contrast PROCEDURE

100 mL of 350 mg omnipaque will be administered via nasogastric tube

Contrast group (CG)

Sterile water PROCEDURE

100 mL of sterile water will be administered via nasogastric tube

Traditional group (TG)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: June 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04