Gastroschisis, Hirschsprung Disease, Incarcerated Hernia, Intestinal Atresia, Intestinal Obstruction, Intestinal Perforation, Intussusception, Malrotation, Meconium Ileus, Necrotizing Enterocolitis, Trauma, Volvulus
Conditions
Keywords
SPY imaging, indocyanine green, pediatric surgery, ICG, intestinal resections, intestinal perfusion
Brief summary
Background: Intestinal resections are commonly performed in the pediatric population. Perfusion of the bowel is one of the most important factors determining the viability of an intestinal anastomosis. Up to date, no ideal method to assess intestinal perfusion has proven its superiority. Objectives: Primary: The aim of this study is to establish the feasibility and impact of the use of indocyanine green technology on intestinal resection margins during elective and emergency pediatric surgeries. Secondary: The secondary outcomes of interest include collection of adverse events and difficulties encountered with the use of the indocyanine green (ICG) technology. Postoperative surgical complications will also be recorded. Study Design: An open observational clinical study will be performed by using a clinical drug (indocyanine green) and medical device (SPY Fluorescence Imaging) to assess intraoperatively intestinal perfusion in a specific pediatric population.
Interventions
DEVICESPY imaging
Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.
DRUGIndocyanine Green
Intravenous injection of indocyanine green to evaluate the intestinal perfusion.
Sponsors
St. Justine's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SPY System utility in intestinal resections in Pediatric Surgery | 1 year | To demonstrate the utility of intra-operative evaluation of intestinal viability using the SPY Fluorescence Imaging System to optimize the location of the resection margins in pediatric surgeries necessitating intestinal resections. \- Rate of intestinal resection margins modifications by using the SPY technology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | 1 year | In days |
| Operative time | 30 days | In minutes |
| Surgical complications | 1 year | * Number of anastomotic leaks * Number of strictures * Number of bowel obstructions |
| Need for additional reoperations | 1 year | Number |
| Need for additional radiology interventions | 1 year | Number |
| Estimated blood losses | 30 days | In ml |
Countries
Canada
Outcome results
None listed