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

Anastomotic Leak Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Anastomotic Leak

• NCT number: NCT02459405
• Study type: Interventional
• Source: University Hospital, Geneva
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Completion date: February 2016