Breakthrough Improvement Collaborative for ColoRectal Cancer (BIC4CRC)

• Conditions: Colorectal Cancer
• Interventions: Other: Learning session 1; Other: Learning session 2; Other: Learning session 3; Other: Learning session 4

• Registration Number: NCT03320317
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Study Start: 2018-03-30
• Primary Completion: 2020-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 950

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal cancer	Learning session 1	-
Colorectal cancer	Learning session 2	-
Colorectal cancer	Learning session 3	-
Colorectal cancer	Learning session 4	-

Primary Outcome Measures

Name	Time	Method
Length of stay	through study completion, an average of 4 months	Number of days in the hospital

Secondary Outcome Measures

Name	Time	Method
30-days readmission rate	through study completion, an average of 4 months	Readmission rate
Mortality rate	through study completion, an average of 4 months	Mortality rate
Complication rate	through study completion, an average of 4 months	Re-intervention, wound complications, surgical site infection, anastomotic leak or stoma related complications

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Vlaams-brabant, Belgium