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Clinical Trials/NCT03982641
NCT03982641UnknownNot Applicable

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

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori8 sites in 1 country1,400 target enrollmentStarted: April 16, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
1,400
Locations
8
Primary Endpoint
Cost relate to HCRU

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • multiple synchronous primary tumours;

Outcomes

Primary Outcomes

Cost relate to HCRU

Time Frame: 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)

Time Frame: 90 day post surgery

To identify the resources delivered to surgical patients. Resource are retrieved from administrative database.

Secondary Outcomes

  • Rate of mortality at 180 days(180 days post surgery)
  • Conversion rate(180 day post surgery)
  • % of patients with adequacy of lymph node sampling(180 days post surgery)
  • % of patients with post-operative complications(180 days post surgery)
  • % of patients with rectal cancer who underwent preoperative chemo-radiation therapy(180 days post surgery)
  • Rate of anastomosis(180 days post surgery)
  • Quality of Total Mesorectal Excision: rate of positive Circumferential Resection Margin in patients with rectal cancer.(180 days post surgery)
  • Rate of mortality at 30 days(30 days post surgery)
  • Rate of mortality at 90 days(90 days post surgery)
  • % of patients discussed in Multidisciplinary team meeting(180 days post surgery)
  • % of patients who underwent minimally invasive resection(180 day post surgery)
  • Rate of Miles procedure(180 days post surgery)
  • Rate of loop ileostomy in patients with rectal cancer(180 days post surgery)
  • Rate of preoperative chemo-radiation therapy in patients with rectal cancer(180 days post surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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