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
Among 31 studies in Colorectal Neoplasms with a site in Finland — 5 open to participants now, 12 under way, 3 of them phase 3. Colorectal Neoplasms · Finland.
Among the 31 studies in Colorectal Neoplasms with a site in Finland, this one is the 7th largest by planned enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2018, is one of 8 with no phase, and was the 19th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →5 of the 31 studies in Colorectal Neoplasms with a site in Finland are open now. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Finland, United States, Australia and 16 more countries
Ages 18+
San Raffaele University · Sites in Finland, United States, Germany and 3 more countries
Ages 18–49 · Healthy volunteers
Helsinki University Central Hospital · Sites in Finland
Ages 18–100
Pia Osterlund · Sites in Finland
Ages 18+
Tampere University Hospital · Sites in Finland
Ages 18+
A study can be open while its sites in Finland have not opened yet or have stopped. Only those recruiting at a site in Finland →
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 13 · Phase 4 1
First in 2003; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,062 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 500 across the 27 interventional studies, 1,200 across the 3 observational. Of the 15 that completed or were terminated, 12 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 31 have an industry lead sponsor. The 10 most frequent:
Oulu University Hospital is the lead sponsor of 40 studies on the registry; 17 are open to participants now.
Oulu University Hospital has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 31 studies in Colorectal Neoplasms with a site in Finland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Sep 2018 (actual). Primary completion is estimated for Jul 2023, 57 months after the start.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 57 months is above that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Oulu University Hospital