Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA (ESCA)

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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Surgery; Financial Benefit; Auditing Activity
• Intervention / Treatment: Procedure: all colorectal cancer surgical procedures

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 Type: Observational
• Enrollment (Anticipated): 1400

Contacts and Locations

• Study Contact: Name: Valentina Danesi, engineer; Phone Number: 00390543739264; Email: valentina.danesi@irst.emr.it

Study Locations

• Italy
  • Piacenza, Italy, 29121
    • Not yet recruiting
    • AOU Chirurgia Generale Ospedale G. Da Saliceto
    • Contact: Patrizio Capelli, physician; Email: p.capelli@ausl.pc.it
    • Principal Investigator: Patrizio Capelli, physician
  • Ravenna, Italy, 48121
    • Recruiting
    • AUO Chirurgia Generale ed Urgenza Ospedale S. Maria delle Croci
    • Contact: Paolo Soliani, physician; Email: paolo.soliani@auslromagna.it
    • Principal Investigator: Paolo Soliani, physician
  • Rimini, Italy, 47923
    • Recruiting
    • Auo Chirurgia Generale Ospedale Degli Infermi
    • Contact: Gianluca Garulli, physician; Email: gianluca.garulli@auslromagna.it
    • Principal Investigator: Gianluca Garulli, physician
  • FC
    • Meldola, FC, Italy, 47014
      • Recruiting
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Contact: Valentina Danesi, Biomedical Engineering; Phone Number: 00390543739264; Email: valentina.danesi@irst.emr.it
      • Principal Investigator: Mattia Altini, physician
  • Forli-Cesena
    • Cesena, Forli-Cesena, Italy, 47521
      • Recruiting
      • AUO Chirurgia Generale e D'Urgenza Ospedale M.Bufalini
      • Contact: Luca Ansaloni, physician; Email: luca.ansaloni@auslromagna.it
      • Principal Investigator: Luca Ansaloni, physician
    • Forlì, Forli-Cesena, Italy, 47121
      • Recruiting
      • AUO CHIRURGIA GENERALE OSPEDALE G. B. Morgagni- Pierantoni
      • Contact: Giorgio Ercolani, physician; Email: giorgio.ercolani2@unibo.it
      • Principal Investigator: Giorgio Ercolani, physician
  • Ravenna
    • Faenza, Ravenna, Italy, 48018
      • Recruiting
      • Auo Chirurgia Generale Ospedale Degli Infermi
      • Contact: Giampaolo Ugolini, physician; Email: giampaolo.ugolini@auslromagna.it
      • Principal Investigator: Giampaolo Ugolini, physician
    • Lugo, Ravenna, Italy
      • Recruiting
      • AUO Chirurgia Generale Ospedale Umberto I
      • Contact: Rosario Mario Tranchino, physician; Email: rosariomario.tranchino@auslromagna.it
      • Principal Investigator: Rosario Mario Tranchino, physician
  • Rimini
    • Riccione, Rimini, Italy, 47838
      • Recruiting
      • AUO Chirurgia Generale Ospedale Ceccarini
      • Contact: Andrea Lucchi, physician; Email: andrea.lucchi@auslromagna.it
      • Principal Investigator: Andrea Lucchi, physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients diagnosed with malignant colorectal cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period will be collected

Description

Inclusion Criteria:

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

Exclusion Criteria:

• multiple synchronous primary tumours;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
health care resources utilization (HCRU)	To identify the resources delivered to surgical patients. Resource are retrieved from administrative database.	90 day post surgery
Cost relate to HCRU	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.	90 day post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients with post-operative complications	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)	180 days post surgery
Rate of mortality at 30 days	To assess mortality rates at 30 days. This outcome is measured from data collected in CRF and from administrative database.	30 days post surgery
Rate of mortality at 90 days	To assess mortality rates at 90 days. This outcome is measured from data collected in CRF and from administrative database.	90 days post surgery
Rate of mortality at 180 days	To assess mortality rates at 180 days. This outcome is measured from data collected in CRF and from administrative database.	180 days post surgery
% of patients discussed in Multidisciplinary team meeting	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.	180 days post surgery
% of patients who underwent minimally invasive resection	To assess the number of minimally invasive resections. This outcome is measured from data collected in CRF.	180 day post surgery
Conversion rate	to assess the rate of conversion surgery. This outcome is measured from data collected in CRF.	180 day post surgery
% of patients with adequacy of lymph node sampling	To assess adequate intraoperative lymph node sampling of colorectal surgery. This outcome will be measured from data collected in CRF.	180 days post surgery
Rate of anastomosis	To assess the rate of anastomosis after low anterior resection vs terminal colostomy. This outcome will be measured from relative data collected in CRF.	180 days post surgery
Rate of Miles procedure	to assess the rate of Miles procedures in rectal cancer patients. This outcome is measured from data collected in CRF.	180 days post surgery
Quality of Total Mesorectal Excision: rate of positive Circumferential Resection Margin in patients with rectal cancer.	To assess the rate of positive Circumferential Resection Margin in rectal cancer patient. This outcome will be measured from data collected in CRF.	180 days post surgery
Rate of loop ileostomy in patients with rectal cancer	To assess the rate of loop ileostomy after rectal cancer resection. This outcome is measured from data collected in CRF.	180 days post surgery
% of patients with rectal cancer who underwent preoperative chemo-radiation therapy	To assess the appropriateness of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF.	180 days post surgery
Rate of preoperative chemo-radiation therapy in patients with rectal cancer	To assess the rate of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF.	180 days post surgery

Collaborators and Investigators

• Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Investigators: Principal Investigator: Mattia Altini, physician, IRST

Publications and helpful links

General Publications

• Massa I, Ghignone F, Ugolini G, Ercolani G, Montroni I, Capelli P, Garulli G, Catena F, Lucchi A, Ansaloni L, Gentili N, Danesi V, Montella MT, Altini M; ESCA Collaborative Group. Emilia-Romagna Surgical Colorectal Cancer Audit (ESCA): a value-based healthcare retro-prospective study to measure and improve the quality of surgical care in colorectal cancer. Int J Colorectal Dis. 2022 Jul;37(7):1727-1738. doi: 10.1007/s00384-022-04203-w. Epub 2022 Jul 2.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: colorectal cancer surgery; auditing activity; economical analysis; surgical performance indicators
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRST153.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No