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

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ClinicalTrials.gov Identifier: NCT03982641
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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

Condition or disease Intervention/treatment
Financial Benefit Colorectal Cancer Surgery Auditing Activity 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Plan for Evaluating Costs and Outcomes of Colorectal Surgery in Emilia-Romagna (Emilia-Romagna Surgical Colorectal Cancer Audit-ESCA)
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. % of patients with post-operative complications [ Time Frame: 180 days post surgery ]
    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)

  2. Rate of mortality at 30 days [ Time Frame: 30 days post surgery ]
    To assess mortality rates at 30 days. This outcome is measured from data collected in CRF and from administrative database.

  3. Rate of mortality at 90 days [ Time Frame: 90 days post surgery ]
    To assess mortality rates at 90 days. This outcome is measured from data collected in CRF and from administrative database.

  4. Rate of mortality at 180 days [ Time Frame: 180 days post surgery ]
    To assess mortality rates at 180 days. This outcome is measured from data collected in CRF and from administrative database.

  5. % of patients discussed in Multidisciplinary team meeting [ Time Frame: 180 days post surgery ]
    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.

  6. % of patients who underwent minimally invasive resection [ Time Frame: 180 day post surgery ]
    To assess the number of minimally invasive resections. This outcome is measured from data collected in CRF.

  7. Conversion rate [ Time Frame: 180 day post surgery ]
    to assess the rate of conversion surgery. This outcome is measured from data collected in CRF.

  8. % of patients with adequacy of lymph node sampling [ Time Frame: 180 days post surgery ]
    To assess adequate intraoperative lymph node sampling of colorectal surgery. This outcome will be measured from data collected in CRF.

  9. Rate of anastomosis [ Time Frame: 180 days post surgery ]
    To assess the rate of anastomosis after low anterior resection vs terminal colostomy. This outcome will be measured from relative data collected in CRF.

  10. Rate of Miles procedure [ Time Frame: 180 days post surgery ]
    to assess the rate of Miles procedures in rectal cancer patients. This outcome is measured from data collected in CRF.

  11. Quality of Total Mesorectal Excision: rate of positive Circumferential Resection Margin in patients with rectal cancer. [ Time Frame: 180 days post surgery ]
    To assess the rate of positive Circumferential Resection Margin in rectal cancer patient. This outcome will be measured from data collected in CRF.

  12. Rate of loop ileostomy in patients with rectal cancer [ Time Frame: 180 days post surgery ]
    To assess the rate of loop ileostomy after rectal cancer resection. This outcome is measured from data collected in CRF.

  13. % of patients with rectal cancer who underwent preoperative chemo-radiation therapy [ Time Frame: 180 days post surgery ]
    To assess the appropriateness of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF.

  14. Rate of preoperative chemo-radiation therapy in patients with rectal cancer [ Time Frame: 180 days post surgery ]
    To assess the rate of preoperative chemo-radiation therapy in rectal cancer patients. This outcome is measured from data collected in CRF.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• multiple synchronous primary tumours;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982641


Contacts
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Contact: Valentina Danesi, engineer 00390543739264 valentina.danesi@irst.emr.it

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

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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT03982641     History of Changes
Other Study ID Numbers: IRST153.07
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
colorectal cancer surgery
auditing activity
economical analysis
surgical performance indicators
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases