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| Name | Class |
|---|---|
| Vilnius University Hospital Santaros Klinikos | OTHER |
| National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive anastomotic testing | Experimental | All patients undergo:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green fluorescent angiography intraluminally and intraperitoneally | Procedure | The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eligijus Poskus, prof. | Vilnius University, Vilnius, Lithuania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute, Vilnius, Lithuania | Vilnius | Lithuania | ||||
| Vilnius University hospital Santaros klinikos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31914032 | Derived | Kryzauskas M, Poskus E, Dulskas A, Bausys A, Jakubauskas M, Imbrasaite U, Makunaite G, Kuliavas J, Bausys R, Stratilatovas E, Strupas K, Poskus T. The problem of colorectal anastomosis safety. Medicine (Baltimore). 2020 Jan;99(2):e18560. doi: 10.1097/MD.0000000000018560. |
| Label | URL |
|---|---|
| Protocol | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 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 |
| Vilnius |
| Lithuania |
| Study results | View source |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |