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

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

Study Description
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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

Study Design
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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
Official Title: A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
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


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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:

  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
Contacts and Locations
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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): NCT04712032


Contacts
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Contact: Alexander Vahrmeijer, MD, PhD 071 526 9111 a.l.vahrmeijer@lumc.nl
Contact: Ruben Meijer, MD 071 526 9111 r.p.j.meijer@lumc.nl

Locations
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Netherlands
Leiden University Medical Center Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Contact: Ruben Meijer, MD    +31 71 526 9111    r.p.j.meijer@lumc.nl   
Contact: Robin Faber       r.a.faber@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
Medical Center Haaglanden
Catharina Ziekenhuis Eindhoven
Haga Hospital
Jeroen Bosch Ziekenhuis
Amphia Hospital
Alrijne Hospital
IJsselland
Investigators
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Principal Investigator: Alexander Vahrmeijer, MD, PhD LUMC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alexander Vahrmeijer, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov 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
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Colonic Diseases