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

Phase 2

Completed

• Conditions: Anastomotic Leak
• Interventions: Procedure: NIR anastomotic perfusion assessment; Device: Near infrared camera

• Registration Number: NCT02459405
• Lead Sponsor: University Hospital, Geneva

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 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

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-04-04
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-02
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIR anastomotic perfusion assessment	Near infrared camera	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.
NIR anastomotic perfusion assessment	NIR anastomotic perfusion assessment	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.

Primary Outcome Measures

Name	Time	Method
Anastomotic leak rate	first 30 days	anastomotic leak rate at 30 post operative days

Secondary Outcome Measures

Name	Time	Method
complication rate	30 days	according to Clavien Dindo classification
Mortality	30 days	30 days mortality
Alteration of the course of surgery due to insufficient vascularisation	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.
Time to get a near infrared signal	during surgery	Time to see a signal during surgery
Time to perform the near infrared procedure	during surgery	measured added time to the procedure

Trial Locations

Locations (4)

Humanitas Universtity Hospitals; 🇮🇹 Milan, Rozzano (Milano), Italy

Dublin University College, department of colorectal surgery; 🇮🇪 Dublin, Ireland

Geneva University Hospitals, Service of Visceral Surgery; 🇨🇭 Geneva, Switzerland

Oxford University Hospitals, Department of colorectal Surgery; 🇬🇧 Oxford, Oxfordshire, United Kingdom