Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Oulu University Hospital2 sites in 1 country1,062 target enrollmentSeptember 24, 2018

ConditionsColorectal Cancer Colorectal Neoplasms Gastrointestinal Cancer Gastrointestinal Neoplasms Diverticulosis, Colonic Gastrointestinal Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Oulu University Hospital
Enrollment: 1062
Locations: 2
Primary Endpoint: Anastomosis leakage rate
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 24, 2018

End Date

December 1, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oulu University Hospital

Responsible Party

Principal Investigator

Olli Helminen

MD, PhD, Resident, Surgery

Oulu University Hospital

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.

Outcomes

Primary Outcomes

Anastomosis leakage rate

Time Frame: 0 to 90 days

Secondary Outcomes

Length of hospital stay(0-365 days)
30- and 90-day mortality(0 to 90 days)
Timing of anastomosis leakage(0 to 90 days)
30- and 90-day complications according to Clavien-Dindo Classification(0 to 90 days)
Time to first bowel movement(0-30 days)
Hospital costs(0 to 90 days)
Severity of anastomosis leakage(0 to 90 days)
Hospital readmission rate(0 to 90 days)
Deep surgical site infections(0 to 90 days)
Operation time(0-600 minutes)
Time to first flatus(0-30 days)
Reoperation rate(0 to 90 days)