Colorectal Cancer, Colorectal Neoplasms, Diverticulosis, Colonic, Gastrointestinal Cancer, Gastrointestinal Disease, Gastrointestinal Neoplasms
Conditions
Keywords
Colorectal surgery, Anastomosis, Anastomosis leak, Fluorescence imaging
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.
Interventions
DEVICEICG fluorescence imaging
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
Sponsors
University of Oulu
Central Finland Hospital District
Tampere University Hospital
Turku University Hospital
Hospital District of Helsinki and Uusimaa
Päijänne Tavastia Central Hospital
Seinäjoki Central Hospital, Seinäjoki, Finland
Oulu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anastomosis leakage rate | 0 to 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30- and 90-day mortality | 0 to 90 days | — |
| Reoperation rate | 0 to 90 days | — |
| 30- and 90-day complications according to Clavien-Dindo Classification | 0 to 90 days | 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. |
| Operation time | 0-600 minutes | Time from the start of the operation until the surgeon has ended the operation |
| Severity of anastomosis leakage | 0 to 90 days | Grade A-C according to International Study Group of Rectal Cancer |
| Length of hospital stay | 0-365 days | Day of the operation is considered the day 0 |
| Deep surgical site infections | 0 to 90 days | Yes/no |
| Hospital readmission rate | 0 to 90 days | — |
| Time to first bowel movement | 0-30 days | Postoperative day when the first bowel movement occurs |
| Time to first flatus | 0-30 days | Postoperative day when the first flatus occurs |
| Hospital costs | 0 to 90 days | — |
| Timing of anastomosis leakage | 0 to 90 days | Days |
Countries
Finland
Contacts
Primary ContactJyrki Kössi, MD, PhD
Backup ContactOlli Helminen, MD, PhD
Outcome results
None listed