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

NCT02459405 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2021-05-04

No results posted yet for this study

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.

Conditions

  • Anastomotic Leak

Interventions

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.

DEVICE

Near infrared camera

Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • University College Dublin

    collaborator OTHER

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Frederic Ris, MD, Prof · University Hospital, Geneva

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Ireland
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459405 on ClinicalTrials.gov