The Problem of Colorectal Anastomosis Safety

Study Overview
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Brief Summary
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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.

Official Title
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Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions

Conditions
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Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms, Colorectal Adenocarcinoma

Intervention / Treatment
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* Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive anastomotic testing<br>All patients undergo: Indocyanine green fluorescent angiography intraluminally and intraperitoneally Air leak test Methylene blue test | Procedure: Indocyanine green fluorescent angiography intraluminally and intraperitoneally<br>* The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis<br>* Other names: Methylene blue test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 0 to 60 days | 
| Reoperation rate | Patients, who needed re-interventions | 0 to 60 days | 
| Intraoperative test leakage | Leakage rate detected intraoperatively after anastomosis testing | 0 to 600 minutes | 
| Time of anastomosis testing | Time from the start of the anastomosis testing till the end | 0 to 600 minutes | 
| Operation time | Time from the start of the operation until the end of the operation | 0 to 600 minutes | 
| 90 days mortality | the mortality of the patients after the operation | 0 to 90 days | 
| Timing of anastomosis leakage | In days after surgery | 0 to 60 days |