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

Q

Queen Savang Vadhana Memorial Hospital, Thailand

Status

Not yet enrolling

Conditions

Small Bowel Obstruction
Small Bowel Adhesion

Treatments

Procedure: Sterile water
Procedure: Low osmolar contrast

Study type

Interventional

Funder types

Other

Identifiers

NCT06140173
029/2565

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

66 participants in 2 patient groups

Contrast group (CG)
Experimental group
Treatment:
Procedure: Low osmolar contrast
Traditional group (TG)
Active Comparator group
Treatment:
Procedure: Sterile water

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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