Clinical trial NCT03602677: Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
Official title: Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Colorectal Neoplasms
Gastrointestinal Cancer
Gastrointestinal Neoplasms
Diverticulosis, Colonic
Gastrointestinal Disease
Keywords: Colorectal surgery
Anastomosis
Anastomosis leak
Fluorescence imaging
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oulu
name: Central Finland Hospital District
name: Tampere University Hospital
name: Turku University Hospital
name: Hospital District of Helsinki and Uusimaa
name: Päijänne Tavastia Central Hospital
name: Seinäjoki Central Hospital, Seinäjoki, Finland
First posted: 2018-07-27
Enrollment: 1062
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study.
* 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:

* Emergent patients
* Patients with proven diverticular abscess and colonic fistulas are excluded
* Patients with planned open surgery are excluded.

Primary outcomes:
measure: Anastomosis leakage rate
timeFrame: 0 to 90 days
Secondary outcomes:
measure: Severity of anastomosis leakage
timeFrame: 0 to 90 days
measure: Timing of anastomosis leakage
timeFrame: 0 to 90 days
measure: Deep surgical site infections
timeFrame: 0 to 90 days
measure: Hospital readmission rate
timeFrame: 0 to 90 days
measure: Reoperation rate
timeFrame: 0 to 90 days
measure: 30- and 90-day complications according to Clavien-Dindo Classification
timeFrame: 0 to 90 days
measure: Operation time
timeFrame: 0-600 minutes
measure: Length of hospital stay
timeFrame: 0-365 days
measure: 30- and 90-day mortality
timeFrame: 0 to 90 days
measure: Time to first bowel movement
timeFrame: 0-30 days
measure: Time to first flatus
timeFrame: 0-30 days
measure: Hospital costs
timeFrame: 0 to 90 days
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
city: Lahti
country: Finland
facility: Päijät Häme Central Hospital
Study officials:
affiliation: Päijänne Tavastia Central Hospital
name: Jyrki Kössi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland
name: Olli Helminen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Heikki Huhta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Päijänne Tavastia Central Hospital
name: Juha Rinne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Finland Central Hospital, Jyväskylä, Finland
name: Matti Kairaluoma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Tero Rautio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: