The Use of Indocyanine Green Angiography in Pediatric Colorectal Surgery: A Feasibility Randomized Controlled Trial

Who is this study for? Pediatric patients with Hirschsprung's disease or anorectal malformations
What treatments are being studied? Indocyanine green
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 needing sections of the bowel to be removed. Some complications of removing parts of the bowel include forming a stricture (a narrowing of the place where the bowel is reattached), and leak from the join. These can be devastating complications, and can significantly impact a patient's quality of life. Indocyanine green (ICG) is a medication that binds to blood vessels and can be visualized using special cameras in the operating room. Once it binds, it lights up green on this equipment. This lends the advantage of being able to better see which parts of the bowel get good blood flow. The theory is that good blood flow can reduce the risks of previously mentioned complications. This has been shown to be true in a variety of bowel surgeries in adults. ICG has also been shown to be safe in children. Given that HD and ARM are both relatively rare conditions (\ 1/5000 live births), research in this area needs to be strategic. The investigators want to ensure that the investigators can recruit enough patients to the study using this protocol such that if this were to be scaled up to a multi-centre trial in the future, the investigators could demonstrate feasibility. The investigators will collect data both on the feasibility of recruitment as the primary outcome and secondary outcomes including stricture, leak, length of stay in hospital, and return to hospital.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 7
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Children's Hospital, London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Jacob Davidson, MSc
Jacob.Davidson@lhsc.on.ca
519-685-8500
Backup
Andreana Butter, MD
Andreana.Butter@lhsc.on.ca
519-685-8500
Time Frame
Start Date: 2021-06-16
Estimated Completion Date: 2024-07
Participants
Target number of participants: 12
Treatments
Experimental: Treatment Arm (Indocyanine Green [ICG])
The ICG group will involve the patient receiving standard care for either HD or ARM, in addition to 1.25mg (maximum dose less than 2mg/kg body weight) of ICG intraoperatively, administered intravenously. ICG will be administered by a member of the anesthesia team when directed by the surgeon (research team member).
No_intervention: Control Arm (Standard Care)
The Standard Care group will have no change to the medical and surgical care they receive while in the hospital. The surgeon will perform the surgery as they normally would outside of this study. This involves a laparoscopic-assisted transanal pullthrough surgery.
Related Therapeutic Areas
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov