Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA
- Conditions
- Colorectal CancerFinancial BenefitAuditing ActivitySurgery
- Interventions
- Procedure: all colorectal cancer surgical procedures
- Registration Number
- NCT03982641
- Brief Summary
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
- Detailed Description
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. A project team composed by experts in colorectal cancer care will be created with the task of identifying the needed resources to allocate to the project and the set of administrative, economic and performance indicators to be measured during the project. A friendly, time-preserving dataset that includes all the items to be collected to measure established indicators will be developed. An analysis on costs and performance indicators will be conducted on colorectal procedures performed between 1 January 2019 and 31 December 2019 within the participating centers. From the second year auditing activity will be implemented among institutions of Emilia-Romagna. Analysis results obtained from the first year of collecting data will be used as a starting feedback report to implement the auditing activity dedicated to colorectal cancer. During the whole second year monthly feedback reports will be drafted and used for monitoring costs and performances outcomes of colorectal surgery procedures between 1 January 2020 and 31 December 2020.
At the end of the second year a final analysis will be performed to compare resources employed for colorectal cancer surgery between the first and second year. Economical and performance data will be collected.
Focusing on costs, the main sources to be used are administrative databases. Full in-hospital costs will be collected for each patient for the time interval between the day of admission for surgery and the following post-operative 90-days. The Diagnosis Related Groups (DRG) standardized payments will be used to calculate inpatient costs.
Another source for cost and performance information is the clinical chart (paper or electronic) in all its parts. The investigators will focus primarily on set of data, that potentially could contribute to define the cost of care on basis of post-operative pathway. Key performance indicators common to both colon and rectal surgery or specific for one of the two surgical procedure will be considered.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1400
- Histological diagnosis of malignant colorectal cancer;
- Underwent colorectal cancer surgery;
• multiple synchronous primary tumours;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Colon surgery all colorectal cancer surgical procedures patients diagnosed with colon cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period Rectal surgery all colorectal cancer surgical procedures patients diagnosed with rectal cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period
- Primary Outcome Measures
Name Time Method Cost relate to HCRU 90 day post-surgery 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.
health care resources utilization (HCRU) 90 day post surgery To identify the resources delivered to surgical patients. Resource are retrieved from administrative database.
- Secondary Outcome Measures
Name Time Method Rate of mortality at 180 days 180 days post surgery To assess mortality rates at 180 days. This outcome is measured from data collected in CRF and from administrative database.
Conversion rate 180 day post surgery to assess the rate of conversion surgery. This outcome is measured from data collected in CRF.
% of patients with adequacy of lymph node sampling 180 days post surgery To assess adequate intraoperative lymph node sampling of colorectal surgery. This outcome will be measured from data collected in CRF.
% of patients with post-operative complications 180 days post surgery 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)
% of patients with rectal cancer who underwent preoperative chemo-radiation therapy 180 days post surgery To assess the appropriateness of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF.
Rate of anastomosis 180 days post surgery To assess the rate of anastomosis after low anterior resection vs terminal colostomy. This outcome will be measured from relative data collected in CRF.
Quality of Total Mesorectal Excision: rate of positive Circumferential Resection Margin in patients with rectal cancer. 180 days post surgery To assess the rate of positive Circumferential Resection Margin in rectal cancer patient. This outcome will be measured from data collected in CRF.
Rate of mortality at 30 days 30 days post surgery To assess mortality rates at 30 days. This outcome is measured from data collected in CRF and from administrative database.
Rate of mortality at 90 days 90 days post surgery To assess mortality rates at 90 days. This outcome is measured from data collected in CRF and from administrative database.
% of patients discussed in Multidisciplinary team meeting 180 days post surgery 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.
% of patients who underwent minimally invasive resection 180 day post surgery To assess the number of minimally invasive resections. This outcome is measured from data collected in CRF.
Rate of Miles procedure 180 days post surgery to assess the rate of Miles procedures in rectal cancer patients. This outcome is measured from data collected in CRF.
Rate of loop ileostomy in patients with rectal cancer 180 days post surgery To assess the rate of loop ileostomy after rectal cancer resection. This outcome is measured from data collected in CRF.
Rate of preoperative chemo-radiation therapy in patients with rectal cancer 180 days post surgery To assess the rate of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF.
Trial Locations
- Locations (8)
Auo Chirurgia Generale Ospedale Degli Infermi
🇮🇹Rimini, Italy
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori
🇮🇹Meldola, FC, Italy
AUO CHIRURGIA GENERALE OSPEDALE G. B. Morgagni- Pierantoni
🇮🇹Forlì, Forli-Cesena, Italy
AUO Chirurgia Generale e D'Urgenza Ospedale M.Bufalini
🇮🇹Cesena, Forli-Cesena, 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 Umberto I
🇮🇹Lugo, Ravenna, Italy
AUO Chirurgia Generale Ospedale Ceccarini
🇮🇹Riccione, Rimini, Italy