NCT02965794

Brief Summary

EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2019

Enrollment Period

4.2 years

First QC Date

August 4, 2014

Last Update Submit

January 27, 2020

Conditions

Keywords

surgerybowelrectumcancernutrition

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Number of days in hospital

    through study completion, an average of 4 months

Secondary Outcomes (1)

  • Time to return to normal diet

    through study completion, an average of 4 months

Study Arms (2)

Usual care

quality of care will be measured in the participating hospitals, using a retrospective patient record analysis

Care Pathway

Care pathways for colorectal cancer

Other: Care pathways for colorectal cancer

Interventions

development of a care pathway for this patient group

Also known as: care pathway, clinical pathway, critical pathway
Care Pathway

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults undergoing surgery for colorectal cancer

You may qualify if:

  • All consecutive scheduled admissions starting September 2, 2013;
  • Minimum age of 18 years;
  • Elective admission for colorectal cancer surgery

You may not qualify if:

  • Emergency (not planned) admission for colorectal cancer surgery;
  • Patients with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KULeuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • van Zelm R, Coeckelberghs E, Sermeus W, Wolthuis A, Bruyneel L, Panella M, Vanhaecht K. A mixed methods multiple case study to evaluate the implementation of a care pathway for colorectal cancer surgery using extended normalization process theory. BMC Health Serv Res. 2021 Jan 4;21(1):11. doi: 10.1186/s12913-020-06011-w.

MeSH Terms

Conditions

Neoplasms

Interventions

Critical Pathways

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Kris Vanhaecht, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Healthcare Quality Management

Study Record Dates

First Submitted

August 4, 2014

First Posted

November 17, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2018

Study Completion

November 1, 2019

Last Updated

January 28, 2020

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations