Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study

Conditions
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Anastomotic Leak

Intervention / Treatment
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* Procedure: NIR anastomotic perfusion assessment
* Device: Near infrared camera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Participant willing and able to comply with the study procedures. Diagnosed with required colon or rectal neoplasia requiring surgical excision by either laparoscopic or open surgery. A negative pregnancy test for women of childbearing potential prior to surgery Able (in the Investigators opinion) and willing to comply with all study requirements Exclusion Criteria: Female participant who is pregnant, lactating or planning pregnancy during the course of the study. Allergy to Indocyanine green. Participant who is undergoing purely palliative surgery or who is terminally ill Subject has other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIR anastomotic perfusion assessment<br>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. | Procedure: NIR anastomotic perfusion assessment<br>* 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.<br>* Other names: Indocyanine assessment of anastomotic microvascularisation;Device: Near infrared camera<br>* Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green<br>* Other names: Pinpoint evaluation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak rate | anastomotic leak rate at 30 post operative days | first 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery, Near infrared, Indocyanine green, anastomotic leak, Prevention of leak