Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage (ICG-COLORAL)

Oulu University Hospital

Status: Enrolling

Conditions: Diverticulosis, Colonic; Gastrointestinal Disease; Gastrointestinal Cancer; Colorectal Neoplasms; Gastrointestinal Neoplasms; Colorectal Cancer

Treatments: Device: ICG fluorescence imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03602677

ICG-COLORAL

Details and patient eligibility

About

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.

Enrollment: 1,062 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,062 participants in 2 patient groups

ICG fluorescence imaging

Experimental group

Description:

Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.

Treatment:

Device: ICG fluorescence imaging

Standard procedure

No Intervention group

Description:

Standard colorectal surgery and anastomosis.