Breakthrough Improvement Collaborative for ColoRectal Cancer (BIC4CRC) (BIC4CRC)

BIC4CRC: Breakthrough Improvement Collaborative for ColoRectal Cancer

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Learning session 1; Other: Learning session 2; Other: Learning session 3; Other: Learning session 4

• Study Type: Observational
• Enrollment (Anticipated): 950

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-brabant
    • Leuven, Vlaams-brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with colorectal cancer admitted for planned surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Number of days in the hospital	through study completion, an average of 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Kom Op Tegen Kanker

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2018
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (ACTUAL): October 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: BIC4CRC/2017/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No