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

May 2, 2021 updated by: Ris Frederic, University Hospital, Geneva

Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging: a Multicentric Prospective Phase II Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

504

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 4
        • Dublin University College, department of colorectal surgery
  • Italy
    • Rozzano (Milano)
      • Milan, Rozzano (Milano), Italy
        • Humanitas Universtity Hospitals
  • Switzerland
      • Geneva, Switzerland, 1224
        • Geneva University Hospitals, Service of Visceral Surgery
  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3
        • Oxford University Hospitals, Department of colorectal Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Indocyanine assessment of anastomotic microvascularisation
Device: Near infrared camera
Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
Other Names:
  • Pinpoint evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic leak rate
Time Frame: first 30 days
anastomotic leak rate at 30 post operative days
first 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

University College Dublin
Oxford University Hospitals NHS Trust

Investigators

  • Principal Investigator: Frederic Ris, MD, Prof, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 4, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 2, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/H0724/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anastomotic Leak

Clinical Trials on NIR anastomotic perfusion assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe