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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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


Sponsor: University Hospital, Geneva

Current Primary Outcome: Anastomotic leak rate [ Time Frame: first 30 days ]

anastomotic leak rate at 30 post operative days


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: April 4, 2015
Date Started: March 2013
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017