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AVOID: Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Sponsor
Leiden University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04712032
Collaborator
Medical Center Haaglanden (Other), Catharina Ziekenhuis Eindhoven (Other), Haga Hospital (Other), Jeroen Bosch Ziekenhuis (Other), Amphia Hospital (Other), Alrijne Hospital (Other), IJsselland (Other)
978
Enrollment
1
Location
2
Arms
27
Anticipated Duration (Months)
36.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: ICG-guided bowel perfusion assessment
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
978 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
National randomized controlled trial.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 :
Jul 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. 90-days Anastomotic Leakage (AL) rate [90 days]

    Anastomotic leakage rate

Secondary Outcome Measures

  1. 30-days Anastomotic Leakage ( AL) rate [30 days]

    Anastomotic leakage rate

  2. complication rate [90 days]

  3. mortality [90 days]

  4. days in hospital stay [90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Leiden University Medical Center Leiden Zuid-Holland Netherlands 2333 ZA

Sponsors and Collaborators

  • Leiden University Medical Center
  • Medical Center Haaglanden
  • Catharina Ziekenhuis Eindhoven
  • Haga Hospital
  • Jeroen Bosch Ziekenhuis
  • Amphia Hospital
  • Alrijne Hospital
  • IJsselland

Investigators

  • Principal Investigator: Alexander Vahrmeijer, MD, PhD, LUMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexander Vahrmeijer, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT04712032
Other Study ID Numbers:
  • P19.079
First Posted:
Jan 15, 2021
Last Update Posted:
Jan 15, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Colorectal Neoplasms
Crohn Disease

Study Results

No Results Posted as of Jan 15, 2021