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Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA

A Plan for Evaluating Costs and Outcomes of Colorectal Surgery in Emilia-Romagna (Emilia-Romagna Surgical Colorectal Cancer Audit-ESCA)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03982641
Acronym
ESCA
Enrollment
1400
Registered
2019-06-11
Start date
2019-04-16
Completion date
2020-12-31
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditing Activity, Colorectal Cancer, Financial Benefit, Surgery

Keywords

colorectal cancer surgery, auditing activity, economical analysis, surgical performance indicators

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.

Interventions

PROCEDUREall colorectal cancer surgical procedures

colorectal cancer surgical procedures

Sponsors

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histological diagnosis of malignant colorectal cancer; * Underwent colorectal cancer surgery;

Exclusion criteria

• multiple synchronous primary tumours;

Design outcomes

Primary

MeasureTime frameDescription
health care resources utilization (HCRU)90 day post surgeryTo identify the resources delivered to surgical patients. Resource are retrieved from administrative database.
Cost relate to HCRU90 day post-surgeryTo 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.

Secondary

MeasureTime frameDescription
Rate of mortality at 90 days90 days post surgeryTo assess mortality rates at 90 days. This outcome is measured from data collected in CRF and from administrative database.
Rate of mortality at 180 days180 days post surgeryTo assess mortality rates at 180 days. This outcome is measured from data collected in CRF and from administrative database.
% of patients discussed in Multidisciplinary team meeting180 days post surgeryTo 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 resection180 day post surgeryTo assess the number of minimally invasive resections. This outcome is measured from data collected in CRF.
Conversion rate180 day post surgeryto assess the rate of conversion surgery. This outcome is measured from data collected in CRF.
% of patients with adequacy of lymph node sampling180 days post surgeryTo assess adequate intraoperative lymph node sampling of colorectal surgery. This outcome will be measured from data collected in CRF.
% of patients with post-operative complications180 days post surgeryTo 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)
Rate of Miles procedure180 days post surgeryto assess the rate of Miles procedures in rectal cancer patients. This outcome is measured from data collected in CRF.
Quality of Total Mesorectal Excision: rate of positive Circumferential Resection Margin in patients with rectal cancer.180 days post surgeryTo assess the rate of positive Circumferential Resection Margin in rectal cancer patient. This outcome will be measured from data collected in CRF.
Rate of loop ileostomy in patients with rectal cancer180 days post surgeryTo assess the rate of loop ileostomy after rectal cancer resection. This outcome is measured from data collected in CRF.
% of patients with rectal cancer who underwent preoperative chemo-radiation therapy180 days post surgeryTo assess the appropriateness of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF.
Rate of preoperative chemo-radiation therapy in patients with rectal cancer180 days post surgeryTo assess the rate of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF.
Rate of anastomosis180 days post surgeryTo assess the rate of anastomosis after low anterior resection vs terminal colostomy. This outcome will be measured from relative data collected in CRF.
Rate of mortality at 30 days30 days post surgeryTo assess mortality rates at 30 days. This outcome is measured from data collected in CRF and from administrative database.

Countries

Italy

Contacts

Primary ContactValentina Danesi, engineer
valentina.danesi@irst.emr.it00390543739264

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026