Clinical trial NCT03320317: Breakthrough Improvement Collaborative for ColoRectal Cancer (BIC4CRC)
Official title: BIC4CRC: Breakthrough Improvement Collaborative for ColoRectal Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colorectal Cancer
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
First posted: 2017-10-25
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with colorectal cancer admitted for planned surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of stay
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: 30-days readmission rate
timeFrame: through study completion, an average of 4 months
measure: Mortality rate
timeFrame: through study completion, an average of 4 months
measure: Complication rate
timeFrame: through study completion, an average of 4 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-brabant
Study officials:
References:
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.
citation: 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.