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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing intestinal resections | Experimental |
Indocyanine green dye (ICG) Dosage: 0.5 mg/kg (diluted with aqueous solution) Maximum: 2 mg/kg Frequency: maximum of 3 boluses Duration: intraoperative use only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPY imaging | Device | Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SPY System utility in intestinal resections in Pediatric Surgery | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications |
| 1 year |
| Length of stay | In days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Piché, MD | St. Justine's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
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| Indocyanine Green | Drug | Intravenous injection of indocyanine green to evaluate the intestinal perfusion. |
|
|
| 1 year |
| Operative time | In minutes | 30 days |
| Estimated blood losses | In ml | 30 days |
| Need for additional reoperations | Number | 1 year |
| Need for additional radiology interventions | Number | 1 year |
| ID | Term |
|---|---|
| D007409 | Intestinal Atresia |
| D020345 | Enterocolitis, Necrotizing |
| D006627 | Hirschsprung Disease |
| D020139 | Gastroschisis |
| D007415 | Intestinal Obstruction |
| D007443 | Intussusception |
| C562456 | Volvulus Of Midgut |
| D045822 | Intestinal Volvulus |
| D000074270 | Meconium Ileus |
| D007416 | Intestinal Perforation |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D008531 | Megacolon |
| D003108 | Colonic Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014102 | Torsion Abnormality |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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