An observational study in Non Metastatic Rectal Cancer, sponsored by Niguarda Hospital. Withdrawn at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Niguarda Hospital · Observational
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.
1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
Browse Rectal Neoplasms studies →Niguarda Hospital is the lead sponsor of 66 studies on the registry; 28 are open to participants now.
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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.
Exclusion Criteria:
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.
Other: Registry
Data collection
Disease free survival
Survival rate
Time frame: at 5 years from surgery
Over all survival
Survival rate
Time frame: at 5 years from surgery
Local recurrences
Recurrences rate
Time frame: at 5 years from surgery
Distant recurrence
Recurrences rate
Time frame: at 5 years from surgery
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.
Time frame: at 5 years from surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Niguarda Hospital