Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging
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|ClinicalTrials.gov Identifier: NCT02459405|
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : May 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Anastomotic Leak||Procedure: NIR anastomotic perfusion assessment Device: Near infrared camera||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||504 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: NIR anastomotic perfusion assessment
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
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.
Other Name: Indocyanine assessment of anastomotic microvascularisation
Device: Near infrared camera
Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
Other Name: Pinpoint evaluation
- Anastomotic leak rate [ Time Frame: first 30 days ]anastomotic leak rate at 30 post operative days
- Time to perform the near infrared procedure [ Time Frame: during surgery ]measured added time to the procedure
- Time to get a near infrared signal [ Time Frame: during surgery ]Time to see a signal during surgery
- complication rate [ Time Frame: 30 days ]according to Clavien Dindo classification
- Mortality [ Time Frame: 30 days ]30 days mortality
- Alteration of the course of surgery due to insufficient vascularisation [ Time Frame: during surgery ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459405
|Dublin University College, department of colorectal surgery|
|Dublin, Ireland, 4|
|Geneva University Hospitals, Service of Visceral Surgery|
|Geneva, Switzerland, 1224|
|Oxford University Hospitals, Department of colorectal Surgery|
|Oxford, Oxfordshire, United Kingdom, OX3|
|Principal Investigator:||Frederic Ris, MD, PD||University Hospital, Geneva|