Colorectal Adenocarcinoma, Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms
Conditions
Brief summary
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.
Interventions
PROCEDUREIndocyanine 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
Sponsors
Vilnius University hospital Santaros klinikos, Vilnius, Lithuania
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Vilnius University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* patients over 18 year * signed written consent * a colorectal anastomosis lower 15 cm from anal verge * elective surgery
Exclusion criteria
* allergy to indocyanine green dye * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of anastomotic leakage | 0 to 60 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate | 0 to 60 days | Patients, who needed re-interventions |
| Intraoperative test leakage | 0 to 600 minutes | Leakage rate detected intraoperatively after anastomosis testing |
| Time of anastomosis testing | 0 to 600 minutes | Time from the start of the anastomosis testing till the end |
| Quality of life before and after the operation | 0 to 60 days | 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). |
| 90 days mortality | 0 to 90 days | the mortality of the patients after the operation |
| Timing of anastomosis leakage | 0 to 60 days | In days after surgery |
| Operation time | 0 to 600 minutes | Time from the start of the operation until the end of the operation |
Countries
Lithuania
Outcome results
None listed