Clinical Trials Directory

Trials / Unknown

UnknownNCT03982641

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
Phase
Study type
Observational
Enrollment
1,400 (estimated)
Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREall colorectal cancer surgical procedurescolorectal cancer surgical procedures

Timeline

Start date
2019-04-16
Primary completion
2020-12-31
Completion
2020-12-31
First posted
2019-06-11
Last updated
2019-06-11

Locations

9 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT03982641. Inclusion in this directory is not an endorsement.