Status:
RECRUITING
Feasibility of Use of Indocyanine Green in Pediatric Colorectal Surgery
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Hirschsprung Disease
Anorectal Malformations
Eligibility:
All Genders
1-7 years
Phase:
PHASE3
Brief Summary
Hirschsprung's Disease (HD) and anorectal malformations (ARM) are both paediatric diseases of the colon and rectum. Both of these conditions require surgery in order to correct them, frequently needin...
Detailed Description
Pediatric colorectal conditions, such as Hirschsprung's disease (HD) and anorectal malformations (ARM), result in significant disease burden in pediatric populations in Canada. Both conditions are pre...
Eligibility Criteria
Inclusion
- All patients with Hirschsprung's disease or anorectal malformations, diagnosed by:
- Clinical evaluation and physical examination
- Radiologic studies including abdominal x-rays and/or contrast enemas
- Pathologic diagnosis after rectal biopsies (HD only)
- Patients greater than one-month of age to 7 years of age at the time of surgery
- Patient requires surgical management for their diagnosis
- Patient/Substitute decision maker (SDM) able to read/write/understand English
Exclusion
- Those patients and SDM unwilling to provide consent
- Pregnant and/or women who are breast feeding
- Patients with a known iodine allergy
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04904081
Start Date
June 16 2021
End Date
July 1 2024
Last Update
March 15 2024
Active Locations (1)
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1
Children's Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A5W9