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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
504
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.
Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
Dublin University College, department of colorectal surgery
Dublin, Ireland
Humanitas Universtity Hospitals
Milan, Rozzano (Milano), Italy
Geneva University Hospitals, Service of Visceral Surgery
Geneva, Switzerland
Oxford University Hospitals, Department of colorectal Surgery
Oxford, Oxfordshire, United Kingdom
Anastomotic leak rate
anastomotic leak rate at 30 post operative days
Time frame: first 30 days
Time to perform the near infrared procedure
measured added time to the procedure
Time frame: during surgery
Time to get a near infrared signal
Time to see a signal during surgery
Time frame: during surgery
complication rate
according to Clavien Dindo classification
Time frame: 30 days
Mortality
30 days mortality
Time frame: 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.
Time frame: during surgery
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