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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
National Cancer Institute, Vilnius, Lithuania
Vilnius, Lithuania
Vilnius University hospital Santaros klinikos
Vilnius, Lithuania
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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