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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03602677
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Olli Helminen, 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Neoplasms Gastrointestinal Cancer Gastrointestinal Neoplasms Diverticulosis, Colonic Gastrointestinal Disease Device: ICG fluorescence imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1062 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICG fluorescence imaging
Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.
Device: ICG fluorescence imaging
The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.

No Intervention: Standard procedure
Standard colorectal surgery and anastomosis.



Primary Outcome Measures :
  1. Anastomosis leakage rate [ Time Frame: 0 to 90 days ]

Secondary Outcome Measures :
  1. Severity of anastomosis leakage [ Time Frame: 0 to 90 days ]
    Grade A-C according to International Study Group of Rectal Cancer

  2. Timing of anastomosis leakage [ Time Frame: 0 to 90 days ]
    Days

  3. Deep surgical site infections [ Time Frame: 0 to 90 days ]
    Yes/no

  4. Hospital readmission rate [ Time Frame: 0 to 90 days ]
  5. Reoperation rate [ Time Frame: 0 to 90 days ]
  6. 30- and 90-day complications according to Clavien-Dindo Classification [ Time Frame: 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.

  7. Operation time [ Time Frame: 0-600 minutes ]
    Time from the start of the operation until the surgeon has ended the operation

  8. Length of hospital stay [ Time Frame: 0-365 days ]
    Day of the operation is considered the day 0

  9. 30- and 90-day mortality [ Time Frame: 0 to 90 days ]
  10. Time to first bowel movement [ Time Frame: 0-30 days ]
    Postoperative day when the first bowel movement occurs

  11. Time to first flatus [ Time Frame: 0-30 days ]
    Postoperative day when the first flatus occurs

  12. Hospital costs [ Time Frame: 0 to 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602677


Contacts
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Contact: Jyrki Kössi, MD, PhD +358381911 jyrki.kossi@phhyky.fi
Contact: Olli Helminen, MD, PhD +358142691811 olli.helminen@oulu.fi

Locations
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Finland
Central Finland Central Hospital Recruiting
Jyväskylä, Finland
Contact: Olli Helminen, MD, PhD       olli.helminen@ksshp.fi   
Päijät Häme Central Hospital Recruiting
Lahti, Finland
Contact: Jyrki Kössi, MD, PhD       jyrki.kossi@phhyky.fi   
Sponsors and Collaborators
Oulu University Hospital
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
Investigators
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Principal Investigator: Jyrki Kössi, MD, PhD Päijänne Tavastia Central Hospital
Principal Investigator: Olli Helminen, MD, PhD Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland
Principal Investigator: Heikki Huhta, MD, PhD Oulu University Hospital
Principal Investigator: Juha Rinne, MD Päijänne Tavastia Central Hospital
Principal Investigator: Matti Kairaluoma, MD, PhD Central Finland Central Hospital, Jyväskylä, Finland
Principal Investigator: Tero Rautio, MD, PhD Oulu University Hospital
  Study Documents (Full-Text)

Documents provided by Olli Helminen, Oulu University Hospital:
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Responsible Party: Olli Helminen, MD, PhD, Resident, Surgery, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT03602677    
Other Study ID Numbers: ICG-COLORAL
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olli Helminen, Oulu University Hospital:
Colorectal surgery
Anastomosis
Anastomosis leak
Fluorescence imaging
Additional relevant MeSH terms:
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Diverticulum
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Diverticulosis, Colonic
Anastomotic Leak
Neoplasms
Digestive System Diseases
Intestinal Neoplasms
Neoplasms by Site
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Pathological Conditions, Anatomical