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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-02-29

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.

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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

Conditions

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Anastomotic Leak

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NIR anastomotic perfusion assessment

Intervention Type 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.

Near infrared camera

Intervention Type DEVICE

Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green

Interventions

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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.

Intervention Type PROCEDURE

Near infrared camera

Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green

Intervention Type DEVICE

Other Intervention Names

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Indocyanine assessment of anastomotic microvascularisation Pinpoint evaluation

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No