Breakthrough Improvement Collaborative for ColoRectal Cancer (BIC4CRC)

Sponsor
KU Leuven (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03320317
Collaborator
Kom Op Tegen Kanker (Other)
950
1
56.1
16.9

Study Details

Study Description

Brief Summary

Colorectal cancer is the most common cancer in Europe and the third worldwide. Approximately 1 in 20 men and 1 in 35 women will develop colorectal cancer at some moment in their life. In Flanders, in 2014, there was an increase in the detection of colorectal cancer with 21% compared to 2013. Early detection improves the prognosis for the patient. In this early stage, colorectal surgery is one of the most important treatments, but it is also complex and has a high complication rate. However, over the last decade, surgical care for patients with colorectal cancer has become more standardized. The use of structured care methods, such as care pathways and protocols, has helped in standardizing care processes. Specifically for patients with colorectal cancer, perioperative care has shifted with the implementation of Enhanced Recovery After Surgery (ERAS) programs. The goal of ERAS- protocols is to optimize the interventions during the perioperative hospitalization period and reduce postoperative complications. Despite the increasing evidence in favor of the use of these standardized protocols, adherence and implementation in daily practice remains challenging.

The primary goal of this quality improvement project is to enhance the standardization of key interventions in the ERAS care process for patients undergoing colorectal surgery.

Therefore, adherence to the ERAS-guidelines will be investigated and hospitals will receive feedback to set up improvement initiatives. Moreover, interactive group sessions and on-site training activities will stimulate knowledge sharing and define best practices.

Condition or Disease Intervention/Treatment Phase
  • Other: Learning session 1
  • Other: Learning session 2
  • Other: Learning session 3
  • Other: Learning session 4

Study Design

Study Type:
Observational
Anticipated Enrollment :
950 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
BIC4CRC: Breakthrough Improvement Collaborative for ColoRectal Cancer
Actual Study Start Date :
Mar 30, 2018
Actual Primary Completion Date :
Sep 30, 2020
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Colorectal cancer

Other: Learning session 1
Learn form international report, Explain key interventions, Explain BIC methodology, Retrospective patient record analysis, Team measures

Other: Learning session 2
Feedback report, Share (inter)national best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis

Other: Learning session 3
Feedback report, Share best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis, Team measures

Other: Learning session 4
Feedback report, Best practice symposium

Outcome Measures

Primary Outcome Measures

  1. Length of stay [through study completion, an average of 4 months]

    Number of days in the hospital

Secondary Outcome Measures

  1. 30-days readmission rate [through study completion, an average of 4 months]

    Readmission rate

  2. Mortality rate [through study completion, an average of 4 months]

    Mortality rate

  3. Complication rate [through study completion, an average of 4 months]

    Re-intervention, wound complications, surgical site infection, anastomotic leak or stoma related complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Minimum age of 18 years

  • Elective admission for colorectal cancer surgery

Exclusion Criteria:
  • Emergency (not planned) admission for colorectal cancer surgery

  • Patients diagnosed with severe dementia or severe concomitant disease that may affect very short term outcome and hence influence deviations from standard acute care

Contacts and Locations

Locations

Site City State Country Postal Code
1 KU Leuven Leuven Vlaams-brabant Belgium 3000

Sponsors and Collaborators

  • KU Leuven
  • Kom Op Tegen Kanker

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kris Vanhaecht, Professor, KU Leuven
ClinicalTrials.gov Identifier:
NCT03320317
Other Study ID Numbers:
  • BIC4CRC/2017/1
First Posted:
Oct 25, 2017
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022