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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,062
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
Central Finland Central Hospital
Jyväskylä, Finland
RECRUITINGPäijät Häme Central Hospital
Lahti, Finland
RECRUITINGAnastomosis 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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