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Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA

I

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Status

Unknown

Conditions

Surgery
Financial Benefit
Colorectal Cancer
Auditing Activity

Treatments

Procedure: all colorectal cancer surgical procedures

Study type

Observational

Funder types

Other

Identifiers

NCT03982641
IRST153.07

Details and patient eligibility

About

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

Full 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.

Enrollment

1,400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• multiple synchronous primary tumours;

Trial design

1,400 participants in 2 patient groups

Colon surgery
Description:
patients diagnosed with colon cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period
Treatment:
Procedure: all colorectal cancer surgical procedures
Rectal surgery
Description:
patients diagnosed with rectal cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period
Treatment:
Procedure: all colorectal cancer surgical procedures

Trial contacts and locations

9

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Central trial contact

Valentina Danesi, engineer

Data sourced from clinicaltrials.gov

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