An observational study in Colorectal Cancer and Anastomotic Leak, sponsored by Zealand University Hospital. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Zealand University Hospital · Observational
Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage.
While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination).
The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously.
This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 114 is below the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Zealand University Hospital is the lead sponsor of 236 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include 115 participants undergoing elective resection with PME or TME for rectal or rectosigmoid cancer through a minimally invasive approach.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery.
Other: Quantitative Indocyanine Green Fluorescence Angiography
Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis
Postoperative anastomotic complications
combined rate of all anastomotic complications
Time frame: 3 months
Number of participants with complications according to Clavien-Dindo Classification
Time frame: 90 days
Number of participants with anastomotic leakage rate, severity (grade A-C)
Time frame: 90 days
Number of participants with postoperative bleeding
Time frame: 10 days
Number of participants with postoperative paralytic ileus
obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal surgery
Time frame: 90 days
Number of participants with wound dehiscence
surgical complication in which a wound ruptures along a surgical incision
Time frame: 1 month
Comprehensive complications index
Time frame: 90 days
Duration of surgery
Time frame: 1 day
Reoperation rate
Time frame: 1 month
Hospital readmission
Number of patients had have to be readmitted to the hospital due to postoperative complications
Time frame: 1 month
Length of hospital stay
Time frame: 1 month
QT interval variability
Continuous ECG-monitoring intraoperatively and postoperatively
Time frame: 2 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in Aug 2024, 36 months.
Of 461 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 132. This study's 36 months is below that.
Counting every sponsor, half of 562 studies reached it within 53 months; a quarter within 28 and three quarters within 103.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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