Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Colorectal Cancer Clinical Trial

— ICG-COLORAL  

Official title:

Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03602677
• Other study ID #: ICG-COLORAL
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Oulu University Hospital
• Contact: Jyrki Kössi, MD, PhD
• Phone: +358381911
• Email: jyrki.kossi[@]phhyky.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1062
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Diseases
• Digestive System Neoplasms
• Diverticulosis, Colonic
• Diverticulum
• Gastrointestinal Cancer
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

Device:
• ICG fluorescence imaging
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä
Finland	Päijät Häme Central Hospital	Lahti

Sponsors (8)

Lead Sponsor	Collaborator
Oulu University Hospital	Central Finland Hospital District, Hospital District of Helsinki and Uusimaa, Päijänne Tavastia Central Hospital, Seinäjoki Central Hospital, Seinäjoki, Finland, Tampere University Hospital, Turku University Hospital, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomosis leakage rate		0 to 90 days
Secondary	Severity of anastomosis leakage	Grade A-C according to International Study Group of Rectal Cancer	0 to 90 days
Secondary	Timing of anastomosis leakage	Days	0 to 90 days
Secondary	Deep surgical site infections	Yes/no	0 to 90 days
Secondary	Hospital readmission rate		0 to 90 days
Secondary	Reoperation rate		0 to 90 days
Secondary	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.	0 to 90 days
Secondary	Operation time	Time from the start of the operation until the surgeon has ended the operation	0-600 minutes
Secondary	Length of hospital stay	Day of the operation is considered the day 0	0-365 days
Secondary	30- and 90-day mortality		0 to 90 days
Secondary	Time to first bowel movement	Postoperative day when the first bowel movement occurs	0-30 days
Secondary	Time to first flatus	Postoperative day when the first flatus occurs	0-30 days
Secondary	Hospital costs		0 to 90 days