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

University Hospitals (UH)

Status and phase: Completed; Phase 2

Conditions: Anastomotic Leak

Treatments: Procedure: NIR anastomotic perfusion assessment; Device: Near infrared camera

Study type: Interventional

Funder types: Other

Identifiers

NCT02459405

10/H0724/13

Details and patient eligibility

About

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.

Full description

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

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

504 participants in 1 patient group

NIR anastomotic perfusion assessment

Experimental group

Description:

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.

Treatment:

Device: Near infrared camera

Procedure: NIR anastomotic perfusion assessment