Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Summary

This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.

Conditions

• Colorectal Cancer
• Colorectal Neoplasms
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Diverticulosis, Colonic
• Gastrointestinal Disease

Interventions

DEVICE

ICG fluorescence imaging

The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.

Sponsors & Collaborators

• University of Oulu

  collaborator OTHER

• Central Finland Hospital District

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Hospital District of Helsinki and Uusimaa

  collaborator OTHER

• Päijänne Tavastia Central Hospital

  collaborator OTHER

• Seinäjoki Central Hospital, Seinäjoki, Finland

  collaborator UNKNOWN

• Oulu University Hospital

  lead OTHER

Principal Investigators

• Jyrki Kössi, MD, PhD · Päijänne Tavastia Central Hospital

• Olli Helminen, MD, PhD · Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland

• Heikki Huhta, MD, PhD · Oulu University Hospital

• Juha Rinne, MD · Päijänne Tavastia Central Hospital

• Matti Kairaluoma, MD, PhD · Central Finland Central Hospital, Jyväskylä, Finland

• Tero Rautio, MD, PhD · Oulu University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-24

Primary Completion

2023-07-01

Completion

2023-12-01

Countries

• Finland

Study Locations