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

Summary

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.

Conditions

• Small Bowel Obstruction
• Contrast Media Adverse Reaction

Interventions

DIAGNOSTIC_TEST

Enteral contrast challenge

Contrast agent, volume of contrast, and contrast dilution were not standardized across sites due to the differences in hospital specific formularies; otherwise, the protocol was standardized across sites. Diatrizoate meglumine (osmolality of 1940 mOsm/kg) was used preferentially at eight sites and Ioversol (702 mOms/kg) at one site. Patients received 30-200ml (based on age or weight depending on site) of enteral contrast followed by X-rays at 8-12 hours and 24 hours after contrast administration.

Sponsors & Collaborators

• Children's Hospital Los Angeles

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Rady Children's Hospital, San Diego

  collaborator OTHER

• Phoenix Children's Hospital

  collaborator OTHER

• Primary Children's Hospital

  collaborator OTHER

• Children's Medical Center Dallas

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Children's Hospital Colorado

  lead OTHER

Principal Investigators

• Shannon N Acker, MD · Children's Hospital Colorado

Eligibility

Min Age

1 Year

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2022-12-31

Completion

2023-12-31

Countries

• United States

Study Locations