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Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates (AVOID)

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. Identifier: NCT04712032
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Medical Center Haaglanden
Catharina Ziekenhuis Eindhoven
Haga Hospital
Jeroen Bosch Ziekenhuis
Amphia Hospital
Alrijne Hospital
Information provided by (Responsible Party):
Alexander Vahrmeijer, Leiden University Medical Center

Brief Summary:
Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Crohn Disease Resectable Colorectal Carcinoma Drug: ICG-guided bowel perfusion assessment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 978 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: National randomized controlled trial.
Masking: Single (Participant)
Masking Description: Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.
Primary Purpose: Prevention
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Image Guided Bowel Anastomosis group
ICG-guided perfusion assessment
Drug: ICG-guided bowel perfusion assessment
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.

No Intervention: Conventional Bowel Anastomosis group
conventional perfusion assessment

Primary Outcome Measures :
  1. 90-days Anastomotic Leakage (AL) rate [ Time Frame: 90 days ]
    Anastomotic leakage rate

Secondary Outcome Measures :
  1. 30-days Anastomotic Leakage ( AL) rate [ Time Frame: 30 days ]
    Anastomotic leakage rate

  2. complication rate [ Time Frame: 90 days ]
  3. mortality [ Time Frame: 90 days ]
  4. days in hospital stay [ Time Frame: 90 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
  2. Patients aged over 18 years old;
  3. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
  4. Signed informed consent prior to any study-mandated procedure;

Exclusion Criteria:

  1. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
  2. Severe liver or kidney insufficiency;
  3. Hyperthyroidism or a benign thyroid tumour;
  4. Pregnant or breastfeeding women;
  5. Scheduled for palliative surgery or terminal ill
  6. Scheduled for a diverting stoma
  7. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination;
  8. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
  9. Emergency surgery

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 identifier (NCT number): NCT04712032

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Contact: Alexander Vahrmeijer, MD, PhD 071 526 9111
Contact: Ruben Meijer, MD 071 526 9111

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Leiden University Medical Center Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Contact: Ruben Meijer, MD    +31 71 526 9111   
Contact: Robin Faber   
Sponsors and Collaborators
Leiden University Medical Center
Medical Center Haaglanden
Catharina Ziekenhuis Eindhoven
Haga Hospital
Jeroen Bosch Ziekenhuis
Amphia Hospital
Alrijne Hospital
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Principal Investigator: Alexander Vahrmeijer, MD, PhD LUMC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alexander Vahrmeijer, Principal Investigator, Leiden University Medical Center Identifier: NCT04712032    
Other Study ID Numbers: P19.079
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Crohn Disease
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Inflammatory Bowel Diseases
Colonic Diseases