Indocyanine Green Fluorescent Imaging in Robotic Assisted Rectosigmoidal Resection; a Multicenter Assessment of Interobserver Variation and Comparison With Computer-based Pixel Analysis
Indocyanine Green Enhanced Fluorescent Angiography: Can it Predict Anastomotic Leakage (AL) After Recto-sigmoid Resection for Malignancy, and Are we Able to Evaluate the Findings? -A Small Multi-centre Trial Study
1 other identifier
observational
55
1 country
1
Brief Summary
A serious complication to colorectal surgery is anastomotic leakage (AL). AL increases post-operative mortality, decreases long-term survival, reduces the functional result and reduces qual-ity of life. Studies suggest that performing an indocyanine-green enhanced fluorescent angi-ography (ICGeFA), blood perfusion in the bowel can be visualised. It is suggested that using this procedure the relative risk of AL is reduced about 54-67%. With this project we wish to evaluate the feasibility of the procedure, and, if proven feasible, to plan further studies evaluating the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedFirst Submitted
Initial submission to the registry
February 18, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedFebruary 23, 2021
February 1, 2021
1.7 years
February 18, 2021
February 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with anastomotic leakage and evaluation of fluorescent imaging in these patients
Primary surgeons peroperative evaluation of fluoresence
30 days
Interventions
Fluorescense imaging used to evaluate blood perfusion
Eligibility Criteria
Patients, older than 18, undergoing robotic surgery for rectal cancer and cancers located low in the sigmoid bowel, \<25 cm form the anal verge.
You may qualify if:
- robotic surgery for rectal cancer and cancers located low in the sigmoid bowel
You may not qualify if:
- Allergy of iodide
- Pregnancy
- Lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Odense, Fyn, 5000, Denmark
Related Publications (1)
Larsen PO, Nerup N, Andersen J, Dohrn N, Klein MF, Brisling S, Salomon S, Andersen PV, Moller S, Svendsen MBS, Rahr HB, Iversen LH, Gogenur I, Qvist N, Ellebaek MB. Anastomotic perfusion assessment with indocyanine green in robot-assisted low-anterior resection, a multicenter study of interobserver variation. Surg Endosc. 2023 May;37(5):3602-3609. doi: 10.1007/s00464-022-09819-1. Epub 2023 Jan 9.
PMID: 36624218DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 18, 2021
First Posted
February 23, 2021
Study Start
April 1, 2017
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
February 23, 2021
Record last verified: 2021-02