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

Primary Purpose

Anastomotic Leak

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NIR anastomotic perfusion assessment
Near infrared camera
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anastomotic Leak focused on measuring Colorectal surgery, Near infrared, Indocyanine green, anastomotic leak, Prevention of leak

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dublin University College, department of colorectal surgery
  • Humanitas Universtity Hospitals
  • Geneva University Hospitals, Service of Visceral Surgery
  • Oxford University Hospitals, Department of colorectal Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NIR anastomotic perfusion assessment

Arm Description

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.

Outcomes

Primary Outcome Measures

Anastomotic leak rate
anastomotic leak rate at 30 post operative days

Secondary Outcome Measures

Time to perform the near infrared procedure
measured added time to the procedure
Time to get a near infrared signal
Time to see a signal during surgery
complication rate
according to Clavien Dindo classification
Mortality
30 days mortality
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.

Full Information

First Posted
April 4, 2015
Last Updated
May 2, 2021
Sponsor
University Hospital, Geneva
Collaborators
Oxford University Hospitals NHS Trust, University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT02459405
Brief Title
Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging
Official Title
Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
Oxford University Hospitals NHS Trust, University College Dublin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak
Keywords
Colorectal surgery, Near infrared, Indocyanine green, anastomotic leak, Prevention of leak

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIR anastomotic perfusion assessment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
NIR anastomotic perfusion assessment
Other Intervention Name(s)
Indocyanine assessment of anastomotic microvascularisation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Near infrared camera
Other Intervention Name(s)
Pinpoint evaluation
Intervention Description
Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
Primary Outcome Measure Information:
Title
Anastomotic leak rate
Description
anastomotic leak rate at 30 post operative days
Time Frame
first 30 days
Secondary Outcome Measure Information:
Title
Time to perform the near infrared procedure
Description
measured added time to the procedure
Time Frame
during surgery
Title
Time to get a near infrared signal
Description
Time to see a signal during surgery
Time Frame
during surgery
Title
complication rate
Description
according to Clavien Dindo classification
Time Frame
30 days
Title
Mortality
Description
30 days mortality
Time Frame
30 days
Title
Alteration of the course of surgery due to insufficient vascularisation
Description
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 Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Ris, MD, Prof
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dublin University College, department of colorectal surgery
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Humanitas Universtity Hospitals
City
Milan
State/Province
Rozzano (Milano)
Country
Italy
Facility Name
Geneva University Hospitals, Service of Visceral Surgery
City
Geneva
ZIP/Postal Code
1224
Country
Switzerland
Facility Name
Oxford University Hospitals, Department of colorectal Surgery
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24566744
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.
Results Reference
background
PubMed Identifier
22098511
Citation
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.
Results Reference
background
PubMed Identifier
29663330
Citation
Ris F, Liot E, Buchs NC, Kraus R, Ismael G, Belfontali V, Douissard J, Cunningham C, Lindsey I, Guy R, Jones O, George B, Morel P, Mortensen NJ, Hompes R, Cahill RA; Near-Infrared Anastomotic Perfusion Assessment Network VOIR. Multicentre phase II trial of near-infrared imaging in elective colorectal surgery. Br J Surg. 2018 Sep;105(10):1359-1367. doi: 10.1002/bjs.10844. Epub 2018 Apr 16.
Results Reference
derived

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

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