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| Name | Class |
|---|---|
| University of Oulu | OTHER |
| Central Finland Hospital District | OTHER |
| Tampere University Hospital | OTHER |
| Turku University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG fluorescence imaging | Experimental | Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging. |
|
| Standard procedure | No Intervention | Standard colorectal surgery and anastomosis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG fluorescence imaging | Device | The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis leakage rate | 0 to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of anastomosis leakage | Grade A-C according to International Study Group of Rectal Cancer | 0 to 90 days |
| Timing of anastomosis leakage | Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jyrki Kössi, MD, PhD | Contact | +358381911 | jyrki.kossi@phhyky.fi | |
| Olli Helminen, MD, PhD | Contact | +358142691811 | olli.helminen@oulu.fi |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Finland Central Hospital | Recruiting | Jyväskylä | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40042831 | Derived | Rinne JKA, Huhta H, Pinta T, Turunen A, Mattila A, Tahkola K, Helminen O, Ohtonen P, Rautio T, Kossi J. Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage: A Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):486-493. doi: 10.1001/jamasurg.2025.0006. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2018 |
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| OTHER_GOV |
| Hospital District of Helsinki and Uusimaa | OTHER |
| Päijänne Tavastia Central Hospital | OTHER |
| Seinäjoki Central Hospital, Seinäjoki, Finland | UNKNOWN |
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| 0 to 90 days |
| Deep surgical site infections | Yes/no | 0 to 90 days |
| Hospital readmission rate | 0 to 90 days |
| Reoperation rate | 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. | 0 to 90 days |
| Operation time | Time from the start of the operation until the surgeon has ended the operation | 0-600 minutes |
| Length of hospital stay | Day of the operation is considered the day 0 | 0-365 days |
| 30- and 90-day mortality | 0 to 90 days |
| Time to first bowel movement | Postoperative day when the first bowel movement occurs | 0-30 days |
| Time to first flatus | Postoperative day when the first flatus occurs | 0-30 days |
| Hospital costs | 0 to 90 days |
| 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 | Principal Investigator |
| Päijät Häme Central Hospital | Recruiting | Lahti | Finland |
|
| Jul 17, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D043963 | Diverticulosis, Colonic |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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