Breakthrough Improvement Collaborative for ColoRectal Cancer (BIC4CRC)

Colorectal Cancer Clinical Trial

— BIC4CRC  

Official title:

BIC4CRC: Breakthrough Improvement Collaborative for ColoRectal Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03320317
• Other study ID #: BIC4CRC/2017/1
• Status: Enrolling by invitation
• Start date: March 30, 2018
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 950
• Est. completion date: December 1, 2025
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Learning session 1
Learn form international report, Explain key interventions, Explain BIC methodology, Retrospective patient record analysis, Team measures
• Learning session 2
Feedback report, Share (inter)national best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis
• Learning session 3
Feedback report, Share best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis, Team measures
• Learning session 4
Feedback report, Best practice symposium

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams-brabant

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Kom Op Tegen Kanker

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

van Zelm R, Coeckelberghs E, Sermeus W, De Buck van Overstraeten A, Weimann A, Seys D, Panella M, Vanhaecht K. Variation in care for surgical patients with colorectal cancer: protocol adherence in 12 European hospitals. Int J Colorectal Dis. 2017 Oct;32(10):1471-1478. doi: 10.1007/s00384-017-2863-z. Epub 2017 Jul 17. — View Citation

van Zelm R, Janssen I, Vanhaecht K, de Buck van Overstraeten A, Panella M, Sermeus W, Coeckelberghs E. Development of a model care pathway for adults undergoing colorectal cancer surgery: Evidence-based key interventions and indicators. J Eval Clin Pract. 2018 Feb;24(1):232-239. doi: 10.1111/jep.12700. Epub 2017 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Number of days in the hospital	through study completion, an average of 4 months
Secondary	30-days readmission rate	Readmission rate	through study completion, an average of 4 months
Secondary	Mortality rate	Mortality rate	through study completion, an average of 4 months
Secondary	Complication rate	Re-intervention, wound complications, surgical site infection, anastomotic leak or stoma related complications	through study completion, an average of 4 months