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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
| University College Dublin | OTHER |
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Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread means of assessing the viability of a laparoscopic anastomosis. The investigators described recently the feasibility of microvascularisation assessment with near-infra red technology (NIR).
The aim of this study is to look at the implementation of this technique in a wider prospective series of patients undergoing colorectal resection.
Multicentric prospective study of 260 consecutive patients undergoing colonic resection and being assessed during the course of surgery for microvascularisation.
After vessel division and after colorectal anastomosis, indocyanine green (2.5mg/ml) is injected intravenously and anastomotic microvascularisation assessed with the PinPoint NIR system (Novadaq, Vancouver, Canada).
Study primary endpoint is the anastomotic leak rate Secondary endpoint are peroperative and post-operative complications according to the Clavien Dindo scale, time of the procedure and time to record a signal as well as any change of the procedure.
This study will be performed on 3 different sites Geneva, Oxford and Dublin University Hospitals
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIR anastomotic perfusion assessment | Experimental | Patient will have their anastomosis assessed after they receive 7.5 to 9 mg of Indocyanine green intravenously (at a concentration of 2.5mg/ml). The microvascularisation assessment will be performed using a near infrared device(Pinpoint device), allowing to increase reality. This procedure will be repeated twice during the surgery, the first time before and the second time after the anastomosis has been done. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIR anastomotic perfusion assessment | Procedure | Patient will have their anastomosis assessed by near infrared technology after indocyanine green has been injected i.v. The procedure will be repeated twice, once before the anastomosis and the second time after the anastomosis has been performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leak rate | anastomotic leak rate at 30 post operative days | first 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to perform the near infrared procedure | measured added time to the procedure | during surgery |
| Time to get a near infrared signal | Time to see a signal during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic Ris, MD, Prof | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dublin University College, department of colorectal surgery | Dublin | 4 | Ireland | |||
| Humanitas Universtity Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24566744 | Background | Ris F, Hompes R, Cunningham C, Lindsey I, Guy R, Jones O, George B, Cahill RA, Mortensen NJ. Near-infrared (NIR) perfusion angiography in minimally invasive colorectal surgery. Surg Endosc. 2014 Jul;28(7):2221-6. doi: 10.1007/s00464-014-3432-y. Epub 2014 Feb 25. | |
| 22098511 | Background | Cahill RA, Ris F, Mortensen NJ. Near-infrared laparoscopy for real-time intra-operative arterial and lymphatic perfusion imaging. Colorectal Dis. 2011 Nov;13 Suppl 7:12-7. doi: 10.1111/j.1463-1318.2011.02772.x. |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Near infrared camera | Device | Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green |
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| during surgery |
| complication rate | according to Clavien Dindo classification | 30 days |
| Mortality | 30 days mortality | 30 days |
| Alteration of the course of surgery due to insufficient vascularisation | If the vascularisation is insufficient during the surgery, the investigators can change the course of the surgery he is performing. For example, it could lead to a second resection to obtain well vascularized tissue for the anastomosis. Any alteration of the regular course of surgery for the safety of the patient is reported. The number of patient requiring an alteration of the course of surgery will be recorded. | during surgery |
| Milan |
| Rozzano (Milano) |
| Italy |
| Geneva University Hospitals, Service of Visceral Surgery | Geneva | 1224 | Switzerland |
| Oxford University Hospitals, Department of colorectal Surgery | Oxford | Oxfordshire | OX3 | United Kingdom |
| 29663330 | Derived | Ris F, Liot E, Buchs NC, Kraus R, Ismael G, Belfontali V, Douissard J, Cunningham C, Lindsey I, Guy R, Jones O, George B, Morel P, Mortensen NJ, Hompes R, Cahill RA; Near-Infrared Anastomotic Perfusion Assessment Network VOIR. Multicentre phase II trial of near-infrared imaging in elective colorectal surgery. Br J Surg. 2018 Sep;105(10):1359-1367. doi: 10.1002/bjs.10844. Epub 2018 Apr 16. |