Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging
1 other identifier
interventional
504
4 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2013
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 4, 2021
May 1, 2021
2.9 years
April 4, 2015
May 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anastomotic leak rate
anastomotic leak rate at 30 post operative days
first 30 days
Secondary Outcomes (5)
Time to perform the near infrared procedure
during surgery
Time to get a near infrared signal
during surgery
complication rate
30 days
Mortality
30 days
Alteration of the course of surgery due to insufficient vascularisation
during surgery
Study Arms (1)
NIR anastomotic perfusion assessment
EXPERIMENTALPatient 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.
Interventions
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.
Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Genevalead
- Oxford University Hospitals NHS Trustcollaborator
- University College Dublincollaborator
Study Sites (4)
Dublin University College, department of colorectal surgery
Dublin, 4, Ireland
Humanitas Universtity Hospitals
Milan, Rozzano (Milano), Italy
Geneva University Hospitals, Service of Visceral Surgery
Geneva, 1224, Switzerland
Oxford University Hospitals, Department of colorectal Surgery
Oxford, Oxfordshire, OX3, United Kingdom
Related Publications (3)
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.
PMID: 24566744BACKGROUNDCahill 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.
PMID: 22098511BACKGROUNDRis 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.
PMID: 29663330DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic Ris, MD, Prof
University Hospital, Geneva
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PD
Study Record Dates
First Submitted
April 4, 2015
First Posted
June 2, 2015
Study Start
March 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
May 4, 2021
Record last verified: 2021-05