Feasibility of Use of Indocyanine Green in Pediatric Colorectal Surgery

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute

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