Clinical trial NCT03982641: Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA
Official title: A Plan for Evaluating Costs and Outcomes of Colorectal Surgery in Emilia-Romagna (Emilia-Romagna Surgical Colorectal Cancer Audit-ESCA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Financial Benefit
Colorectal Cancer
Surgery
Auditing Activity
Keywords: colorectal cancer surgery
auditing activity
economical analysis
surgical performance indicators
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• multiple synchronous primary tumours;

Primary outcomes:
measure: health care resources utilization (HCRU)
timeFrame: 90 day post surgery
measure: Cost relate to HCRU
timeFrame: 90 day post-surgery
Secondary outcomes:
measure: % of patients with post-operative complications
timeFrame: 180 days post surgery
measure: Rate of mortality at 30 days
timeFrame: 30 days post surgery
measure: Rate of mortality at 90 days
timeFrame: 90 days post surgery
measure: Rate of mortality at 180 days
timeFrame: 180 days post surgery
measure: % of patients discussed in Multidisciplinary team meeting
timeFrame: 180 days post surgery
measure: % of patients who underwent minimally invasive resection
timeFrame: 180 day post surgery
measure: Conversion rate
timeFrame: 180 day post surgery
measure: % of patients with adequacy of lymph node sampling
timeFrame: 180 days post surgery
measure: Rate of anastomosis
timeFrame: 180 days post surgery
measure: Rate of Miles procedure
timeFrame: 180 days post surgery
measure: Quality of Total Mesorectal Excision: rate of positive Circumferential Resection Margin in patients with rectal cancer.
timeFrame: 180 days post surgery
measure: Rate of loop ileostomy in patients with rectal cancer
timeFrame: 180 days post surgery
measure: % of patients with rectal cancer who underwent preoperative chemo-radiation therapy
timeFrame: 180 days post surgery
measure: Rate of preoperative chemo-radiation therapy in patients with rectal cancer
timeFrame: 180 days post surgery
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo studio e la cura dei tumori
state: FC
city: Cesena
country: Italy
facility: AUO Chirurgia Generale e D'Urgenza Ospedale M.Bufalini
state: Forli-Cesena
city: Forlì
country: Italy
facility: AUO CHIRURGIA GENERALE OSPEDALE G. B. Morgagni- Pierantoni
state: Forli-Cesena
city: Faenza
country: Italy
facility: Auo Chirurgia Generale Ospedale Degli Infermi
state: Ravenna
city: Lugo
country: Italy
facility: AUO Chirurgia Generale Ospedale Umberto I
state: Ravenna
city: Riccione
country: Italy
facility: AUO Chirurgia Generale Ospedale Ceccarini
state: Rimini
city: Piacenza
country: Italy
facility: AOU Chirurgia Generale Ospedale G. Da Saliceto
city: Ravenna
country: Italy
facility: AUO Chirurgia Generale ed Urgenza Ospedale S. Maria delle Croci
city: Rimini
country: Italy
facility: Auo Chirurgia Generale Ospedale Degli Infermi
Study officials:
affiliation: IRST
name: Mattia Altini, physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.