NCT02459405

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Anastomotic Leak

Interventions

Type	Name	Description
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.
DEVICE	Near infrared camera	Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-06-02
• Last updated: 2021-05-04

Locations

4 sites across 4 countries: Ireland, Italy, Switzerland, United Kingdom