Financial BenefitESCANCT03982641
Emilia-Romagna Surgical Colorectal Cancer Audit- ESCA
An observational study of Financial Benefit and Colorectal Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 9 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Financial Benefit, Colorectal Cancer, Surgery
- What is being tested?
- all colorectal cancer surgical procedures
- Type of treatment
- Surgery or procedure
- How many people
- 1,400 participants
- Where
- 9 sitesItaly
- Study dates
- 16 Apr 2019to 31 Dec 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Histological diagnosis of malignant colorectal cancer;
- Underwent colorectal cancer surgery;
Who cannot join
- multiple synchronous primary tumours;
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites, 9 recruiting
- Recruiting
AUO Chirurgia Generale e D'Urgenza Ospedale M.Bufalini
Cesena, Forli-Cesena, 47521
Luca Ansaloni, physician, luca.ansaloni@auslromagna.it
Luca Ansaloni, physician
- Recruiting
Auo Chirurgia Generale Ospedale Degli Infermi
Faenza, Ravenna, 48018
Giampaolo Ugolini, physician, giampaolo.ugolini@auslromagna.it
Giampaolo Ugolini, physician
- Recruiting
AUO CHIRURGIA GENERALE OSPEDALE G. B. Morgagni- Pierantoni
Forlì, Forli-Cesena, 47121
Giorgio Ercolani, physician, giorgio.ercolani2@unibo.it
Giorgio Ercolani, physician
- Recruiting
AUO Chirurgia Generale Ospedale Umberto I
Lugo, Ravenna
Rosario Mario Tranchino, physician, rosariomario.tranchino@auslromagna.it
Rosario Mario Tranchino, physician
- Recruiting
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori
Meldola, FC, 47014
Valentina Danesi, Biomedical Engineering, 00390543739264, valentina.danesi@irst.emr.it
Mattia Altini, physician
- Not yet recruiting
AOU Chirurgia Generale Ospedale G. Da Saliceto
Piacenza, 29121
Patrizio Capelli, physician, p.capelli@ausl.pc.it
Patrizio Capelli, physician
- Recruiting
AUO Chirurgia Generale ed Urgenza Ospedale S. Maria delle Croci
Ravenna, 48121
Paolo Soliani, physician, paolo.soliani@auslromagna.it
Paolo Soliani, physician
- Recruiting
AUO Chirurgia Generale Ospedale Ceccarini
Riccione, Rimini, 47838
Andrea Lucchi, physician, andrea.lucchi@auslromagna.it
Andrea Lucchi, physician
- Recruiting
Auo Chirurgia Generale Ospedale Degli Infermi
Rimini, 47923
Gianluca Garulli, physician, gianluca.garulli@auslromagna.it
Gianluca Garulli, physician
About this study
Official title: 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
Read the 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
- Financial Benefit, Colorectal Cancer, Surgery, Auditing Activity
- Being tested
- all colorectal cancer surgical procedures
- Keywords
- colorectal cancer surgery, auditing activity, economical analysis, surgical performance indicators
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all colorectal cancer surgical proceduresProcedure or surgery
colorectal cancer surgical procedures
| Study group | Role | What they receive |
|---|---|---|
| Colon surgery | patients diagnosed with colon cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period Receives: Procedure: all 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 Receives: Procedure: all colorectal cancer surgical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
health care resources utilization (HCRU)
To identify the resources delivered to surgical patients. Resource are retrieved from administrative database.
Measured: 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.
Measured: 90 day post-surgery
Secondary outcomes (14)
% 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 day post surgery
Conversion rate
to assess the rate of conversion surgery. This outcome is measured from data collected in CRF.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start16 Apr 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Financial BenefitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mattia Altini, physician, Principal investigator, IRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982641
- Sponsor's protocol ID
- IRST153.07
- Acronym
- ESCA
- Status last verified
- Jun 2019
- First submitted
- 28 May 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35779080
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Plan for Evaluating Costs and Outcomes of Colorectal Surgery in Emilia-Romagna (Emilia-Romagna Surgical Colorectal Cancer Audit-ESCA)
- ClinicalTrials.gov ID
- NCT03982641
- Acronym / sponsor ID
- ESCA / IRST153.07
- Conditions
- Financial Benefit, Colorectal Cancer, Surgery, Auditing Activity
- Keywords
- colorectal cancer surgery, auditing activity, economical analysis, surgical performance indicators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colon surgery | – | Procedure: all colorectal cancer surgical procedurespatients diagnosed with colon cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period |
| Rectal surgery | – | Procedure: all colorectal cancer surgical procedurespatients diagnosed with rectal cancer, who undergone at least one surgical procedure at one of participating hospitals during the observational period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Histological diagnosis of malignant colorectal cancer;
- Underwent colorectal cancer surgery;
Key exclusion criteria (1 listed)
- multiple synchronous primary tumours;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all colorectal cancer surgical procedurescolorectal cancer surgical procedures | Procedure or surgery | Colon surgery, Rectal surgery |
Primary outcome
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.
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.
14 secondary outcomes
% of patients with post-operative complications
Time frame: 180 days post surgery
Rate of mortality at 30 days
Time frame: 30 days post surgery
Rate of mortality at 90 days
Time frame: 90 days post surgery
Rate of mortality at 180 days
Time frame: 180 days post surgery
% of patients discussed in Multidisciplinary team meeting
Time frame: 180 days post surgery
% of patients who underwent minimally invasive resection
Time frame: 180 day post surgery
Conversion rate
Time frame: 180 day post surgery
% of patients with adequacy of lymph node sampling
Time frame: 180 days post surgery
Rate of anastomosis
Time frame: 180 days post surgery
Rate of Miles procedure
Time frame: 180 days post surgery
Quality of Total Mesorectal Excision: rate of positive Circumferential Resection Margin in patients with rectal cancer.
Time frame: 180 days post surgery
Rate of loop ileostomy in patients with rectal cancer
Time frame: 180 days post surgery
% of patients with rectal cancer who underwent preoperative chemo-radiation therapy
Time frame: 180 days post surgery
Rate of preoperative chemo-radiation therapy in patients with rectal cancer
Time frame: 180 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Derived from this study: PubMed 35779080Massa 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.
- Individual participant dataSharing planned: No
Related trials for Financial Benefit
Not yet recruiting
Healthier Wealthier Families In East London: HWFinEL
Mental Health, Financial Wellbeing
Recruiting
Benfit of Remote Monitoring in Pacemaker
Pacemaker Implanted Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattia Altini, physician principal investigator
IRST
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Financial Benefit and Colorectal Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina Danesi, engineer (00390543739264, valentina.danesi@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health care resources utilization (HCRU) (time frame: 90 day post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.