Colorectal Cancer Clinical Trial
— ESCAOfficial title:
A Plan for Evaluating Costs and Outcomes of Colorectal Surgery in Emilia-Romagna (Emilia-Romagna Surgical Colorectal Cancer Audit-ESCA)
Focus of this project is to evaluate the possible financial benefit resulting from an optimization of surgical outcomes throughout a collaborative and systematic auditing activity.The primary objective of this analysis is to assess the employed resources by National Health System related to surgical activities for primary colorectal cancer during a collaborative and systematic auditing activity in 8 Surgical Units of Emilia-Romagna
Status | Recruiting |
Enrollment | 1400 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological diagnosis of malignant colorectal cancer; - Underwent colorectal cancer surgery; Exclusion Criteria: • multiple synchronous primary tumours; |
Country | Name | City | State |
---|---|---|---|
Italy | AUO Chirurgia Generale e D'Urgenza Ospedale M.Bufalini | Cesena | Forli-Cesena |
Italy | Auo Chirurgia Generale Ospedale Degli Infermi | Faenza | Ravenna |
Italy | AUO CHIRURGIA GENERALE OSPEDALE G. B. Morgagni- Pierantoni | Forlì | Forli-Cesena |
Italy | AUO Chirurgia Generale Ospedale Umberto I | Lugo | Ravenna |
Italy | Istituto Scientifico Romagnolo per lo studio e la cura dei tumori | Meldola | FC |
Italy | AOU Chirurgia Generale Ospedale G. Da Saliceto | Piacenza | |
Italy | AUO Chirurgia Generale ed Urgenza Ospedale S. Maria delle Croci | Ravenna | |
Italy | AUO Chirurgia Generale Ospedale Ceccarini | Riccione | Rimini |
Italy | Auo Chirurgia Generale Ospedale Degli Infermi | Rimini |
Lead Sponsor | Collaborator |
---|---|
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | health care resources utilization (HCRU) | To identify the resources delivered to surgical patients. Resource are retrieved from administrative database. | 90 day post surgery | |
Primary | Cost relate to HCRU | To identify the significant cost drivers for the surgical management of colorectal cancer patients and to verify the impact on economic resource consumption of the systematic auditing activities. Costs are retrieved from adminatrative database. | 90 day post-surgery | |
Secondary | % of patients with post-operative complications | To assess the frequency of post-operative complications, unplanned re-interventions and re-admission. This outcome is measured from data collected in Case Report Form (CRF) | 180 days post surgery | |
Secondary | Rate of mortality at 30 days | To assess mortality rates at 30 days. This outcome is measured from data collected in CRF and from administrative database. | 30 days post surgery | |
Secondary | Rate of mortality at 90 days | To assess mortality rates at 90 days. This outcome is measured from data collected in CRF and from administrative database. | 90 days post surgery | |
Secondary | Rate of mortality at 180 days | To assess mortality rates at 180 days. This outcome is measured from data collected in CRF and from administrative database. | 180 days post surgery | |
Secondary | % of patients discussed in Multidisciplinary team meeting | To assess the number of patient discussed within a multidisciplinary team meeting before colon rectal surgery. This outcome is measured from data collected in CRF. | 180 days post surgery | |
Secondary | % of patients who underwent minimally invasive resection | To assess the number of minimally invasive resections. This outcome is measured from data collected in CRF. | 180 day post surgery | |
Secondary | Conversion rate | to assess the rate of conversion surgery. This outcome is measured from data collected in CRF. | 180 day post surgery | |
Secondary | % of patients with adequacy of lymph node sampling | To assess adequate intraoperative lymph node sampling of colorectal surgery. This outcome will be measured from data collected in CRF. | 180 days post surgery | |
Secondary | Rate of anastomosis | To assess the rate of anastomosis after low anterior resection vs terminal colostomy. This outcome will be measured from relative data collected in CRF. | 180 days post surgery | |
Secondary | Rate of Miles procedure | to assess the rate of Miles procedures in rectal cancer patients. This outcome is measured from data collected in CRF. | 180 days post surgery | |
Secondary | Quality of Total Mesorectal Excision: rate of positive Circumferential Resection Margin in patients with rectal cancer. | To assess the rate of positive Circumferential Resection Margin in rectal cancer patient. This outcome will be measured from data collected in CRF. | 180 days post surgery | |
Secondary | Rate of loop ileostomy in patients with rectal cancer | To assess the rate of loop ileostomy after rectal cancer resection. This outcome is measured from data collected in CRF. | 180 days post surgery | |
Secondary | % of patients with rectal cancer who underwent preoperative chemo-radiation therapy | To assess the appropriateness of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF. | 180 days post surgery | |
Secondary | Rate of preoperative chemo-radiation therapy in patients with rectal cancer | To assess the rate of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF. | 180 days post surgery |
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