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Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage (ICG-COLORAL)

Primary Purpose

Colorectal Cancer, Colorectal Neoplasms, Gastrointestinal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
ICG fluorescence imaging
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal surgery, Anastomosis, Anastomosis leak, Fluorescence imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study.
  • Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold).

Exclusion Criteria:

  • Emergent patients
  • Patients with proven diverticular abscess and colonic fistulas are excluded
  • Patients with planned open surgery are excluded.

Sites / Locations

  • Central Finland Central HospitalRecruiting
  • Päijät Häme Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICG fluorescence imaging

Standard procedure

Arm Description

Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.

Standard colorectal surgery and anastomosis.

Outcomes

Primary Outcome Measures

Anastomosis leakage rate

Secondary Outcome Measures

Severity of anastomosis leakage
Grade A-C according to International Study Group of Rectal Cancer
Timing of anastomosis leakage
Days
Deep surgical site infections
Yes/no
Hospital readmission rate
Reoperation rate
30- and 90-day complications according to Clavien-Dindo Classification
Clavien-Dindo Score from Grade 0 (no complications) to Grade V (Death of a patient). Five grades and additionally Grade III and IV will be divided to a and b.
Operation time
Time from the start of the operation until the surgeon has ended the operation
Length of hospital stay
Day of the operation is considered the day 0
30- and 90-day mortality
Time to first bowel movement
Postoperative day when the first bowel movement occurs
Time to first flatus
Postoperative day when the first flatus occurs
Hospital costs

Full Information

First Posted
March 25, 2018
Last Updated
March 24, 2023
Sponsor
Oulu University Hospital
Collaborators
University of Oulu, Central Finland Hospital District, Tampere University Hospital, Turku University Hospital, Hospital District of Helsinki and Uusimaa, Päijänne Tavastia Central Hospital, Seinäjoki Central Hospital, Seinäjoki, Finland
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1. Study Identification

Unique Protocol Identification Number
NCT03602677
Brief Title
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
Acronym
ICG-COLORAL
Official Title
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oulu University Hospital
Collaborators
University of Oulu, Central Finland Hospital District, Tampere University Hospital, Turku University Hospital, Hospital District of Helsinki and Uusimaa, Päijänne Tavastia Central Hospital, Seinäjoki Central Hospital, Seinäjoki, Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Neoplasms, Gastrointestinal Cancer, Gastrointestinal Neoplasms, Diverticulosis, Colonic, Gastrointestinal Disease
Keywords
Colorectal surgery, Anastomosis, Anastomosis leak, Fluorescence imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1062 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICG fluorescence imaging
Arm Type
Experimental
Arm Description
Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.
Arm Title
Standard procedure
Arm Type
No Intervention
Arm Description
Standard colorectal surgery and anastomosis.
Intervention Type
Device
Intervention Name(s)
ICG fluorescence imaging
Intervention Description
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
Primary Outcome Measure Information:
Title
Anastomosis leakage rate
Time Frame
0 to 90 days
Secondary Outcome Measure Information:
Title
Severity of anastomosis leakage
Description
Grade A-C according to International Study Group of Rectal Cancer
Time Frame
0 to 90 days
Title
Timing of anastomosis leakage
Description
Days
Time Frame
0 to 90 days
Title
Deep surgical site infections
Description
Yes/no
Time Frame
0 to 90 days
Title
Hospital readmission rate
Time Frame
0 to 90 days
Title
Reoperation rate
Time Frame
0 to 90 days
Title
30- and 90-day complications according to Clavien-Dindo Classification
Description
Clavien-Dindo Score from Grade 0 (no complications) to Grade V (Death of a patient). Five grades and additionally Grade III and IV will be divided to a and b.
Time Frame
0 to 90 days
Title
Operation time
Description
Time from the start of the operation until the surgeon has ended the operation
Time Frame
0-600 minutes
Title
Length of hospital stay
Description
Day of the operation is considered the day 0
Time Frame
0-365 days
Title
30- and 90-day mortality
Time Frame
0 to 90 days
Title
Time to first bowel movement
Description
Postoperative day when the first bowel movement occurs
Time Frame
0-30 days
Title
Time to first flatus
Description
Postoperative day when the first flatus occurs
Time Frame
0-30 days
Title
Hospital costs
Time Frame
0 to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study. Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold). Exclusion Criteria: Emergent patients Patients with proven diverticular abscess and colonic fistulas are excluded Patients with planned open surgery are excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jyrki Kössi, MD, PhD
Phone
+358381911
Email
jyrki.kossi@phhyky.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Olli Helminen, MD, PhD
Phone
+358142691811
Email
olli.helminen@oulu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyrki Kössi, MD, PhD
Organizational Affiliation
Päijänne Tavastia Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olli Helminen, MD, PhD
Organizational Affiliation
Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heikki Huhta, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juha Rinne, MD
Organizational Affiliation
Päijänne Tavastia Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matti Kairaluoma, MD, PhD
Organizational Affiliation
Central Finland Central Hospital, Jyväskylä, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tero Rautio, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland Central Hospital
City
Jyväskylä
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olli Helminen, MD, PhD
Email
olli.helminen@oulu.fi
Facility Name
Päijät Häme Central Hospital
City
Lahti
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyrki Kössi, MD, PhD
Email
jyrki.kossi@phhyky.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

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