NCT03982641

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

May 28, 2019

Last Update Submit

June 10, 2019

Conditions

Keywords

colorectal cancer surgeryauditing activityeconomical analysissurgical performance indicators

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

  • % of patients with post-operative complications

    180 days post surgery

  • Rate of mortality at 30 days

    30 days post surgery

  • Rate of mortality at 90 days

    90 days post surgery

  • Rate of mortality at 180 days

    180 days post surgery

  • % of patients discussed in Multidisciplinary team meeting

    180 days post surgery

  • +9 more secondary outcomes

Study Arms (2)

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

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

Interventions

colorectal cancer surgical procedures

Colon surgeryRectal surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • multiple synchronous primary tumours;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Istituto Scientifico Romagnolo per lo studio e la cura dei tumori

Meldola, FC, 47014, Italy

RECRUITING

AUO Chirurgia Generale e D'Urgenza Ospedale M.Bufalini

Cesena, Forli-Cesena, 47521, Italy

RECRUITING

AUO CHIRURGIA GENERALE OSPEDALE G. B. Morgagni- Pierantoni

Forlì, Forli-Cesena, 47121, Italy

RECRUITING

Auo Chirurgia Generale Ospedale Degli Infermi

Faenza, Ravenna, 48018, Italy

RECRUITING

AUO Chirurgia Generale Ospedale Umberto I

Lugo, Ravenna, Italy

RECRUITING

AUO Chirurgia Generale Ospedale Ceccarini

Riccione, Rimini, 47838, Italy

RECRUITING

AOU Chirurgia Generale Ospedale G. Da Saliceto

Piacenza, 29121, Italy

NOT YET RECRUITING

AUO Chirurgia Generale ed Urgenza Ospedale S. Maria delle Croci

Ravenna, 48121, Italy

RECRUITING

Auo Chirurgia Generale Ospedale Degli Infermi

Rimini, 47923, Italy

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mattia Altini, physician

    IRST

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Danesi, engineer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 11, 2019

Study Start

April 16, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 11, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations