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The primary purpose of this registry is to prospectively collect data from different Mini-invasive Colo-rectal Units in Northern Italy with a standardization of the pre-operative, intra-operative and post operative setting for patients operated on for non metastatic rectal cancer with curative intent. The secondary aim is to collect in a registry the compliance to oncological treatments and the oncological outcomes for the same patients
Study parameters
Patients with an histological diagnosis of rectal cancer will undergo pre-operative staging as follow:
Symptoms at presentation (Haemorrhagic framework ,alvo alteration, pain) will be collected. For Locally advance rectal cancer neo adjuvant chemoradiotherapy will be planned. Grey dose received and total dose of chemotherapy administrated together with eventual toxicity and reasons for non completing the therapy will be collected. Patients will be re-staged with pelvic MRI, endorectal US, colonoscopy. Radiological and endoscopic disease response to neo adjuvant treatment criteria will be noted.
Intraoperative analysed parameters will include :
Post operative complication will be described according to Clavien Dindo complication scale. Day of discharge and eventual post discharge complication will be evaluated. Application of an ERAS protocol will be added only for at least 80% of ERAS colo-rectal items satisfied. Indication to eventual adjuvant therapy given within a multidisciplinary setting will be noted. Type of therapy, duration of the treatment and a full description of the compliance to the treatment will be described. Oncological follow up will be performed according to National Comprehensive Cancer Network guidelines. Functional follow up will be done yearly with the Low Anterior Resection Syndrome Score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non metastatic rectal cancer | Patients receiving the diagnosis of non metastatic rectal cancer and the indication for a curative treatment will be enrolled in the registry. The study population will consist of all the patients enrolled in the participating centres from the start of the rectal cancer registry on. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Registry | Other | Data collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Survival rate | at 5 years from surgery |
| Over all survival | Survival rate | at 5 years from surgery |
| Local recurrences | Recurrences rate | at 5 years from surgery |
| Distant recurrence | Recurrences rate | at 5 years from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life Scale (QOLS) | QOLS CRC-specific questionnaire FACT-C score analisys. QOLS CRC Range: 7 maximum 1 minimum. 7 score represents a better value. FACT-C Range maximum 4 minimum 0. 4 score represents better value. | at 5 years from surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving the diagnosis of non metastatic rectal cancer and the indication for a curative treatment will be enrolled in the registry. The study population will consist of all the patients enrolled in the participating centres from the start of the rectal cancer registry on.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italia | 20162 | Italy |
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| ID | Term |
|---|---|
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011996 | Records |
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| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |