Recruiting
Phase 3

Indocyanine Green

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04904081

Conditions

Hirschsprung Disease

Anorectal Malformations

Eligibility Criteria

Sex: All

Age: 0 - 7

Healthy Volunteers: Not accepted

Interventions

Indocyanine green

Study Details

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 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.

Conditions

Hirschsprung Disease

Anorectal Malformations

Study ID

NCT04904081

Start date

Jun 16, 2021

Status verified date

Mar, 2024

Completion date

Jul, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 7

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Indocyanine green

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).

Primary outcome measure

  • The number of eligible paediatric patients treated for HD or ARM at the local institute that would qualify for participation in this trial. [ Time Frame: 12 months ]
  • The number of eligible paediatric patients treated for HD or ARM that enroll in this study during the recruitment period of this study. [ Time Frame: 12 months ]
  • The number of eligible paediatric patients treated for HD or ARM that enroll in this study and attend al required study visits. [ Time Frame: 12 months ]
  • The number of eligible paediatric patients treated for HD or ARM that enrolled in this study but are lost to attrition/drop-out during the study [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital, London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5W9

Contacts

Principal Investigator:

Andreana Butter, MD

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-03-15.