Using Indocyanine Green to Improve Surgery for Pediatric Colorectal Conditions
The Use of Indocyanine Green Angiography in Pediatric Colorectal Surgery: A Feasibility Randomized Controlled Trial
PHASE3 · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT04904081
This study is testing if a special dye can help doctors see blood flow better during surgery for kids with bowel problems, to see if it makes the surgery safer and more successful.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 1 Month to 7 Years |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT04904081 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the feasibility of using indocyanine green (ICG) during surgeries for pediatric colorectal conditions such as Hirschsprung disease and anorectal malformations. ICG is a dye that helps visualize blood flow in the bowel, potentially reducing complications like strictures and leaks after surgery. The study aims to assess whether ICG can enhance surgical outcomes by providing better assessment of bowel viability. Participants will include children aged 1 month to 7 years who require surgical intervention for these conditions.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 month to 7 years diagnosed with Hirschsprung disease or anorectal malformations who require surgical management.
Not a fit: Patients with known iodine allergies or those who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for children undergoing colorectal surgery.
How similar studies have performed: Previous studies in adults have shown success with the use of ICG for assessing bowel perfusion, suggesting potential applicability in pediatric cases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All patients with Hirschsprung's disease or anorectal malformations, diagnosed by: 1. Clinical evaluation and physical examination 2. Radiologic studies including abdominal x-rays and/or contrast enemas 3. Pathologic diagnosis after rectal biopsies (HD only) 2. Patients greater than one-month of age to 7 years of age at the time of surgery 3. Patient requires surgical management for their diagnosis 4. Patient/Substitute decision maker (SDM) able to read/write/understand English Exclusion Criteria: 1. Those patients and SDM unwilling to provide consent 2. Pregnant and/or women who are breast feeding 3. Patients with a known iodine allergy
Where this trial is running
London, Ontario
- Children's Hospital, London Health Sciences Centre — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Andreana Butter, MD — Pediatric Surgeon, Children's Hospital, LHSC
- Study coordinator: Jacob Davidson, MSc
- Email: Jacob.Davidson@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hirschsprung Disease, Anorectal Malformations