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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459405
• Other study ID #: 10/H0724/13
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: February 2016

Study information

• Verified date: May 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

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

Locations

Country	Name	City	State
Ireland	Dublin University College, department of colorectal surgery	Dublin
Italy	Humanitas Universtity Hospitals	Milan	Rozzano (Milano)
Switzerland	Geneva University Hospitals, Service of Visceral Surgery	Geneva
United Kingdom	Oxford University Hospitals, Department of colorectal Surgery	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	Oxford University Hospitals NHS Trust, University College Dublin

Countries where clinical trial is conducted

Ireland,  Italy,  Switzerland,  United Kingdom, 

References & Publications (2)

Cahill RA, Ris F, Mortensen NJ. Near-infrared laparoscopy for real-time intra-operative arterial and lymphatic perfusion imaging. Colorectal Dis. 2011 Nov;13 Suppl 7:12-7. doi: 10.1111/j.1463-1318.2011.02772.x. — View Citation

Ris F, Hompes R, Cunningham C, Lindsey I, Guy R, Jones O, George B, Cahill RA, Mortensen NJ. Near-infrared (NIR) perfusion angiography in minimally invasive colorectal surgery. Surg Endosc. 2014 Jul;28(7):2221-6. doi: 10.1007/s00464-014-3432-y. Epub 2014 Feb 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leak rate	anastomotic leak rate at 30 post operative days	first 30 days
Secondary	Time to perform the near infrared procedure	measured added time to the procedure	during surgery
Secondary	Time to get a near infrared signal	Time to see a signal during surgery	during surgery
Secondary	complication rate	according to Clavien Dindo classification	30 days
Secondary	Mortality	30 days mortality	30 days
Secondary	Alteration of the course of surgery due to insufficient vascularisation	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.	during surgery