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Register:	ClinicalTrials.gov
Last refreshed on:	29 March 2021
Main ID:	NCT04020939
Date of registration:	02/07/2019
Prospective Registration:	Yes
Primary sponsor:	St. Justine's Hospital
Public title:	The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
Scientific title:	The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.
Date of first enrolment:	March 16, 2020
Target sample size:	35
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT04020939
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Canada

Contacts

Name:	Nelson Piché, MD
Address:
Telephone:
Email:
Affiliation:	St. Justine's Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients < 16 years old

- Admitted between September 2019 and September 2020

- Patients undergoing a surgery at CHUSJ

- Any diagnosis requiring intra-abdominal intestinal resection (including stoma
reversal)

- Written informed consent form from the parents or legal guardian

Exclusion Criteria:

- Patients > 16 years old

- Patients with known allergy or sensitivity to iodine

- Patients with known kidney or liver failure

- Patients with known severe cardiac or pulmonary diseases

- Informed consent unobtained or impossible due to refusal of parents, language barrier,
or diminished comprehension

Age minimum: N/A
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Intussusception

Malrotation

Intestinal Perforation

Meconium Ileus

Incarcerated Hernia

Trauma

Gastroschisis

Hirschsprung Disease

Intestinal Atresia

Intestinal Obstruction

Volvulus

Necrotizing Enterocolitis

Intervention(s)

Drug: Indocyanine Green

Device: SPY imaging

Primary Outcome(s)

SPY System utility in intestinal resections in Pediatric Surgery [Time Frame: 1 year]

Secondary Outcome(s)

Need for additional radiology interventions [Time Frame: 1 year]

Surgical complications [Time Frame: 1 year]

Need for additional reoperations [Time Frame: 1 year]

Length of stay [Time Frame: 1 year]

Operative time [Time Frame: 30 days]

Estimated blood losses [Time Frame: 30 days]

Secondary ID(s)

2020-2359

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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