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

NCT06101719 | Completed

• 1 other identifier: 20-2538
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 9

Brief 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. 1.Determine if an enteral contrast challenge is safe in the evaluation of children with ASBO
2. 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

Keywords

Pediatric adhesive small bowel obstruction; enteral contrast challenge

Outcome Measures

Primary Outcomes (1)

• Number of patients who required an operation

  operative lysis of adhesions performed due to failure of non operative management

  1 year

Secondary Outcomes (2)

• Total hospital length of stay in days

  1 year

• Adverse events resulting from contrast administration

  1 year

Study Arms (2)

Contrast Group

Inclusion criteria: children 1-20 years diagnosed with an adhesive small bowel obstruction by an attending pediatric surgeon and underwent a trial of nonoperative management (NOM) on hospital admission and received an enteral contrast challenge. Exclusion criteria included peritonitis, suspicion of incarcerated or internal hernia, active intra-abdominal malignancy, inflammatory bowel disease, \<4 weeks since the most recent abdominal operation,45 pneumatosis, pneumoperitoneum, or known contrast allergy. If the attending surgeon made the decision to take a child directly to the operating room (OR) with no attempt at NOM, these children were excluded. Children under one year of age were excluded as the rate of successful NOM is lower in this age group

Diagnostic Test: Enteral contrast challenge

No Contrast group

Inclusion criteria: children 1-20 years diagnosed with an adhesive small bowel obstruction by an attending pediatric surgeon and underwent a trial of nonoperative management (NOM) on hospital admission and who did not receive an enteral contrast challenge. Exclusion criteria included peritonitis, suspicion of incarcerated or internal hernia, active intra-abdominal malignancy, inflammatory bowel disease, \<4 weeks since the most recent abdominal operation, pneumatosis, pneumoperitoneum, or known contrast allergy. If the attending surgeon made the decision to take a child directly to the operating room (OR) with no attempt at NOM, these children were excluded. Children under one year of age were excluded as the rate of successful NOM is lower in this age group

Interventions

Enteral contrast challenge DIAGNOSTIC_TEST

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.

Contrast Group

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with adhesive small bowel obstruction admitted to one of 9 participating sites and underwent a trial of non operative management

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

Sponsors & Collaborators

• Children's Hospital Colorado: lead
• Children's Hospital Los Angeles: collaborator
• University of California, San Francisco: collaborator
• Oregon Health and Science University: collaborator
• Rady Children's Hospital, San Diego: collaborator
• Phoenix Children's Hospital: collaborator
• Primary Children's Hospital: collaborator
• Children's Medical Center Dallas: collaborator
• Seattle Children's Hospital: collaborator

Study Sites (9)

Phoenix Children's Hospital

Phoenix, Arizona, 85006, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

UCSF Benioff Children's Hospital

Oakland, California, 94609, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75390, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Study Officials

• Shannon N Acker, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatric Surgery

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 26, 2023
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (9)