An interventional study of Indocyanine green fluorescent angiography intraluminally and intraperitoneally in Colorectal Cancer, Colorectal Carcinoma and Colorectal Neoplasms, sponsored by Vilnius University. Completed at 2 sites in Lithuania. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Vilnius University · Not applicable, Interventional, and Diagnostic
This is a prospective cohort pilot study. The investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation will determine the final anastomotic leak risk.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 60 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Vilnius University is the lead sponsor of 60 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients undergo: 1. Indocyanine green fluorescent angiography intraluminally and intraperitoneally 2. Air leak test 3. Methylene blue test
Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally
The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
Also known as: Air leak test, Methylene blue test
Rate of anastomotic leakage
The number of patients, who had clinical or radiological anastomotic leakage. Proctography will be performed 6-8 days and 4-6 weeks after the primary operation.
Time frame: 0 to 60 days
Quality of life before and after the operation
Using low anterior resection syndrome score (the LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).
Time frame: 0 to 60 days
Quality of life before and after the operation
Using QLQ-C30 questionnaire. To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) before operation and 4-6 weeks after the operation. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Time frame: 0 to 60 days
Reoperation rate
Patients, who needed re-interventions
Time frame: 0 to 60 days
Intraoperative test leakage
Leakage rate detected intraoperatively after anastomosis testing
Time frame: 0 to 600 minutes
Time of anastomosis testing
Time from the start of the anastomosis testing till the end
Time frame: 0 to 600 minutes
Operation time
Time from the start of the operation until the end of the operation
Time frame: 0 to 600 minutes
90 days mortality
the mortality of the patients after the operation
Time frame: 0 to 90 days
Timing of anastomosis leakage
In days after surgery
Time frame: 0 to 60 days
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Vilnius University