Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Not Applicable

Recruiting

• Conditions: Colorectal Neoplasms; Diverticulosis, Colonic; Gastrointestinal Disease; Colorectal Cancer; Gastrointestinal Neoplasms; Gastrointestinal Cancer
• Interventions: Device: ICG fluorescence imaging

• Registration Number: NCT03602677
• Lead Sponsor: Oulu University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-25
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-27
• Study Start: 2018-09-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1062

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Anastomosis leakage rate	0 to 90 days

Secondary Outcome Measures

Name	Time	Method
Reoperation rate	0 to 90 days
Length of hospital stay	0-365 days	Day of the operation is considered the day 0
30- and 90-day mortality	0 to 90 days
Timing of anastomosis leakage	0 to 90 days	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.
Time to first bowel movement	0-30 days	Postoperative day when the first bowel movement occurs
Hospital costs	0 to 90 days
Severity of anastomosis leakage	0 to 90 days	Grade A-C according to International Study Group of Rectal Cancer
Hospital readmission rate	0 to 90 days
Deep surgical site infections	0 to 90 days	Yes/no
Operation time	0-600 minutes	Time from the start of the operation until the surgeon has ended the operation
Time to first flatus	0-30 days	Postoperative day when the first flatus occurs

Trial Locations

Locations (2)

Päijät Häme Central Hospital; 🇫🇮 Lahti, Finland

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland