Back to resultsAnastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates (AVOID)
Primary Purpose
Colo-rectal Cancer, Crohn Disease, Resectable Colorectal Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
ICG-guided bowel perfusion assessment
Sponsored by
About this trial
This is an interventional prevention trial for Colo-rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
- Patients aged over 18 years old;
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
- Signed informed consent prior to any study-mandated procedure;
Exclusion Criteria:
- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
- Severe liver or kidney insufficiency;
- Hyperthyroidism or a benign thyroid tumour;
- Pregnant or breastfeeding women;
- Scheduled for palliative surgery or terminal ill
- Scheduled for a diverting stoma
- 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;
- Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
- Emergency surgery
Sites / Locations
- Leiden University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Image Guided Bowel Anastomosis group
Conventional Bowel Anastomosis group
Arm Description
ICG-guided perfusion assessment
conventional perfusion assessment
Outcomes
Primary Outcome Measures
90-days Anastomotic Leakage (AL) rate
Anastomotic leakage rate
Secondary Outcome Measures
30-days Anastomotic Leakage ( AL) rate
Anastomotic leakage rate
complication rate
mortality
days in hospital stay
Full Information
NCT ID
NCT04712032
First Posted
January 14, 2021
Last Updated
January 14, 2021
Sponsor
Leiden University Medical Center
Collaborators
Medical Center Haaglanden, Catharina Ziekenhuis Eindhoven, Haga Hospital, Jeroen Bosch Ziekenhuis, Amphia Hospital, Alrijne Hospital, IJsselland
1. Study Identification
Unique Protocol Identification Number
NCT04712032
Brief Title
Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates
Acronym
AVOID
Official Title
A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Medical Center Haaglanden, Catharina Ziekenhuis Eindhoven, Haga Hospital, Jeroen Bosch Ziekenhuis, Amphia Hospital, Alrijne Hospital, IJsselland
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer, Crohn Disease, Resectable Colorectal Carcinoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
National randomized controlled trial.
Masking
Participant
Masking Description
Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.
Allocation
Randomized
Enrollment
978 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Image Guided Bowel Anastomosis group
Arm Type
Experimental
Arm Description
ICG-guided perfusion assessment
Arm Title
Conventional Bowel Anastomosis group
Arm Type
No Intervention
Arm Description
conventional perfusion assessment
Intervention Type
Drug
Intervention Name(s)
ICG-guided bowel perfusion assessment
Intervention Description
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.
Primary Outcome Measure Information:
Title
90-days Anastomotic Leakage (AL) rate
Description
Anastomotic leakage rate
Time Frame
90 days
Secondary Outcome Measure Information:
Title
30-days Anastomotic Leakage ( AL) rate
Description
Anastomotic leakage rate
Time Frame
30 days
Title
complication rate
Time Frame
90 days
Title
mortality
Time Frame
90 days
Title
days in hospital stay
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
Patients aged over 18 years old;
Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
Signed informed consent prior to any study-mandated procedure;
Exclusion Criteria:
Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
Severe liver or kidney insufficiency;
Hyperthyroidism or a benign thyroid tumour;
Pregnant or breastfeeding women;
Scheduled for palliative surgery or terminal ill
Scheduled for a diverting stoma
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;
Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
Emergency surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Vahrmeijer, MD, PhD
Phone
071 526 9111
Email
a.l.vahrmeijer@lumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben Meijer, MD
Phone
071 526 9111
Email
r.p.j.meijer@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Vahrmeijer, MD, PhD
Organizational Affiliation
LUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Meijer, MD
Phone
+31 71 526 9111
Email
r.p.j.meijer@lumc.nl
First Name & Middle Initial & Last Name & Degree
Robin Faber
Email
r.a.faber@lumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35365509
Citation
Meijer RPJ, Faber RA, Bijlstra OD, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Mieog JSD, Burggraaf K, Vahrmeijer AL, Hilling DE; AVOID study group. AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery. BMJ Open. 2022 Apr 1;12(4):e051144. doi: 10.1136/bmjopen-2021-051144.
Results Reference
derived
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Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates
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