Use of a Water Soluble Contrast-Based Protocol to Assist in the Management of Pediatric Adhesive Small Bowel Obstruction

Completed

Conditions studied: Small Bowel Obstruction, Contrast Media Adverse Reaction

In brief

The goal of this prospective observational study is to evaluate the diagnostic and therapeutic utility of an enteral contrast challenge for pediatric patients with adhesive small bowel obstruction (ASBO). The aims are to 1. Determine if an enteral contrast challenge is safe in the evaluation of children with ASBO 2. Determine if an enteral contrast challenge decreases the need for operation among children with ASBO Children with ASBO who are cared for at one of 9 participating sites who undergo a trial of non operative management will be observed. Comparisons will be made between those who receive and enteral contrast challenge and those who do not. Outcomes to be evaluated include adverse events related to the contrast, rate of operative intervention, and hospital length of stay.

Key facts

Study ID

NCT06101719

Run by

Children's Hospital Colorado

People needed

136

Starts

2020-10-01

Expected to finish

2023-12-31

Last updated by the study team

2024-08-23

Who can join

Age: 1 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• children 1-20 years
• diagnosed with an adhesive small bowel obstruction by an attending pediatric surgeon
• underwent a trial of nonoperative management on hospital admission

You may not qualify if…

• peritonitis
• suspicion of incarcerated or internal hernia
• active intra-abdominal malignancy
• inflammatory bowel disease
• less than four weeks since most recent abdominal operations
• pneumatosis
• pneumoperitoneum
• known contrast allergy

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• UCSF Benioff Children's Hospital — Oakland, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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