Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA

Colorectal Cancer Clinical Trial

— ESCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982641
• Other study ID #: IRST153.07
• Status: Recruiting
• Start date: April 16, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Valentina Danesi, engineer
• Phone: 00390543739264
• Email: valentina.danesi[@]irst.emr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological diagnosis of malignant colorectal cancer;

• Underwent colorectal cancer surgery;

Exclusion Criteria:

• multiple synchronous primary tumours;

Related Conditions & MeSH terms

• Auditing Activity
• Colorectal Cancer
• Colorectal Neoplasms
• Financial Benefit
• Surgery

Intervention

Procedure:
• all colorectal cancer surgical procedures
colorectal cancer surgical procedures

Locations

Country	Name	City	State
Italy	AUO Chirurgia Generale e D'Urgenza Ospedale M.Bufalini	Cesena	Forli-Cesena
Italy	Auo Chirurgia Generale Ospedale Degli Infermi	Faenza	Ravenna
Italy	AUO CHIRURGIA GENERALE OSPEDALE G. B. Morgagni- Pierantoni	Forlì	Forli-Cesena
Italy	AUO Chirurgia Generale Ospedale Umberto I	Lugo	Ravenna
Italy	Istituto Scientifico Romagnolo per lo studio e la cura dei tumori	Meldola	FC
Italy	AOU Chirurgia Generale Ospedale G. Da Saliceto	Piacenza
Italy	AUO Chirurgia Generale ed Urgenza Ospedale S. Maria delle Croci	Ravenna
Italy	AUO Chirurgia Generale Ospedale Ceccarini	Riccione	Rimini
Italy	Auo Chirurgia Generale Ospedale Degli Infermi	Rimini

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health care resources utilization (HCRU)	To identify the resources delivered to surgical patients. Resource are retrieved from administrative database.	90 day post surgery
Primary	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	% 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
Secondary	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
Secondary	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
Secondary	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
Secondary	% 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
Secondary	% 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
Secondary	Conversion rate	to assess the rate of conversion surgery. This outcome is measured from data collected in CRF.	180 day post surgery
Secondary	% 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	% 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
Secondary	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