Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
NCT ID: NCT03602677
Last Updated: 2023-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1062 participants
INTERVENTIONAL
2018-09-24
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ICG fluorescence imaging
Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.
ICG fluorescence imaging
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
Standard procedure
Standard colorectal surgery and anastomosis.
No interventions assigned to this group
Interventions
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ICG fluorescence imaging
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with proven diverticular abscess and colonic fistulas are excluded
* Patients with planned open surgery are excluded.
18 Years
ALL
No
Sponsors
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University of Oulu
OTHER
Central Finland Hospital District
OTHER
Tampere University Hospital
OTHER
Turku University Hospital
OTHER_GOV
Hospital District of Helsinki and Uusimaa
OTHER
Päijänne Tavastia Central Hospital
OTHER
Seinäjoki Central Hospital, Seinäjoki, Finland
UNKNOWN
Oulu University Hospital
OTHER
Responsible Party
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Olli Helminen
MD, PhD, Resident, Surgery
Principal Investigators
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Jyrki Kössi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Päijänne Tavastia Central Hospital
Olli Helminen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland
Heikki Huhta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Juha Rinne, MD
Role: PRINCIPAL_INVESTIGATOR
Päijänne Tavastia Central Hospital
Matti Kairaluoma, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Central Finland Central Hospital, Jyväskylä, Finland
Tero Rautio, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Locations
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Central Finland Central Hospital
Jyväskylä, , Finland
Päijät Häme Central Hospital
Lahti, , Finland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ICG-COLORAL
Identifier Type: -
Identifier Source: org_study_id
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