An interventional study of ICG fluorescence imaging in Colorectal Cancer, Colorectal Neoplasms and Gastrointestinal Cancer, sponsored by Oulu University Hospital. Status unknown at 2 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Oulu University Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.
Device: ICG fluorescence imaging
Standard colorectal surgery and anastomosis.
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
Anastomosis leakage rate
Time frame: 0 to 90 days
Severity of anastomosis leakage
Grade A-C according to International Study Group of Rectal Cancer
Time frame: 0 to 90 days
Timing of anastomosis leakage
Days
Time frame: 0 to 90 days
Deep surgical site infections
Yes/no
Time frame: 0 to 90 days
Hospital readmission rate
Time frame: 0 to 90 days
Reoperation rate
Time frame: 0 to 90 days
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.
Time frame: 0 to 90 days
Operation time
Time from the start of the operation until the surgeon has ended the operation
Time frame: 0-600 minutes
Length of hospital stay
Day of the operation is considered the day 0
Time frame: 0-365 days
30- and 90-day mortality
Time frame: 0 to 90 days
Time to first bowel movement
Postoperative day when the first bowel movement occurs
Time frame: 0-30 days
Time to first flatus
Postoperative day when the first flatus occurs
Time frame: 0-30 days
Hospital costs
Time frame: 0 to 90 days
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Oulu University Hospital