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

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ClinicalTrials.gov Identifier: NCT02459405
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
Oxford University Hospitals NHS Trust
University College Dublin
Information provided by (Responsible Party):
Ris Frederic, 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.


Condition or disease Intervention/treatment Phase
Anastomotic Leak Procedure: NIR anastomotic perfusion assessment Device: Near infrared camera Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study
Study Start Date : March 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: 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.

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.
Other Name: Indocyanine assessment of anastomotic microvascularisation

Device: Near infrared camera
Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
Other Name: Pinpoint evaluation




Primary Outcome Measures :
  1. Anastomotic leak rate [ Time Frame: first 30 days ]
    anastomotic leak rate at 30 post operative days


Secondary Outcome Measures :
  1. Time to perform the near infrared procedure [ Time Frame: during surgery ]
    measured added time to the procedure

  2. Time to get a near infrared signal [ Time Frame: during surgery ]
    Time to see a signal during surgery

  3. complication rate [ Time Frame: 30 days ]
    according to Clavien Dindo classification

  4. Mortality [ Time Frame: 30 days ]
    30 days mortality

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459405


Locations
Ireland
Dublin University College, department of colorectal surgery
Dublin, Ireland, 4
Switzerland
Geneva University Hospitals, Service of Visceral Surgery
Geneva, Switzerland, 1224
United Kingdom
Oxford University Hospitals, Department of colorectal Surgery
Oxford, Oxfordshire, United Kingdom, OX3
Sponsors and Collaborators
University Hospital, Geneva
Oxford University Hospitals NHS Trust
University College Dublin
Investigators
Principal Investigator: Frederic Ris, MD, PD University Hospital, Geneva

Publications:
Responsible Party: Ris Frederic, MD, PD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02459405     History of Changes
Other Study ID Numbers: 10/H0724/13
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Ris Frederic, University Hospital, Geneva:
Colorectal surgery
Near infrared
Indocyanine green
anastomotic leak
Prevention of leak

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes