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

Sponsor

Oulu University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03602677

Collaborator

University of Oulu (Other), Central Finland Hospital District (Other), Tampere University Hospital (Other), Turku University Hospital (Other), Hospital District of Helsinki and Uusimaa (Other), Päijänne Tavastia Central Hospital (Other), Seinäjoki Central Hospital, Seinäjoki, Finland (Other)

1,062

Enrollment

Locations

Arms

50.2

Anticipated Duration (Months)

531

Patients Per Site

10.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colorectal Neoplasms Gastrointestinal Cancer Gastrointestinal Neoplasms Diverticulosis, Colonic Gastrointestinal Disease	Device: ICG fluorescence imaging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1062 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Actual Study Start Date :

Sep 24, 2018

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICG fluorescence imaging Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.	Device: ICG fluorescence imaging The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
No Intervention: Standard procedure Standard colorectal surgery and anastomosis.

Arm

Intervention/Treatment

Experimental: ICG fluorescence imaging

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

Device: ICG fluorescence imaging

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

No Intervention: Standard procedure

Standard colorectal surgery and anastomosis.

Outcome Measures

Primary Outcome Measures

Anastomosis leakage rate [0 to 90 days]

Secondary Outcome Measures

Severity of anastomosis leakage [0 to 90 days]
Grade A-C according to International Study Group of Rectal Cancer
Timing of anastomosis leakage [0 to 90 days]
Days
Deep surgical site infections [0 to 90 days]
Yes/no
Hospital readmission rate [0 to 90 days]
Reoperation rate [0 to 90 days]
30- and 90-day complications according to Clavien-Dindo Classification [0 to 90 days]
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 [0-600 minutes]
Time from the start of the operation until the surgeon has ended the operation
Length of hospital stay [0-365 days]
Day of the operation is considered the day 0
30- and 90-day mortality [0 to 90 days]
Time to first bowel movement [0-30 days]
Postoperative day when the first bowel movement occurs
Time to first flatus [0-30 days]
Postoperative day when the first flatus occurs
Hospital costs [0 to 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Finland Central Hospital	Jyväskylä		Finland
2	Päijät Häme Central Hospital	Lahti		Finland

Investigators

Principal Investigator: Jyrki Kössi, MD, PhD, Päijänne Tavastia Central Hospital
Principal Investigator: Olli Helminen, MD, PhD, Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland
Principal Investigator: Heikki Huhta, MD, PhD, Oulu University Hospital
Principal Investigator: Juha Rinne, MD, Päijänne Tavastia Central Hospital
Principal Investigator: Matti Kairaluoma, MD, PhD, Central Finland Central Hospital, Jyväskylä, Finland
Principal Investigator: Tero Rautio, MD, PhD, Oulu University Hospital