- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04739605
Quality of Recovery Using QoR-15 in Enhanced Recovery After Colorectal Surgery.
Postoperative Patient-reported Quality of Recovery in Colorectal Surgery Patients Under Enhanced Recovery After Surgery Program Using QoR-15.
Study Overview
Status
Detailed Description
For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of Liège has been labelled as reference center for ERP after colorectal surgery by a French-speaking organization GRACE (French-speaking group for Enhanced Recovery after Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits of such programs, few studies have investigated postoperative patient-related quality of recovery of patients who have had ERP.
This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery according to an ERP at CHU Liège.The QoR15 survey will be performed preoperatively and repeated postoperatively at hospital or via telephone calls on Day + 1, Day +2; Day + 3, Day 7 and Day + 14. The total score and the answers at the subsections will be correlated with the medical and surgical characteristics of the patients.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pierre-Yves Hardy, MD
- Phone Number: 00 32-4-3667180
- Email: pyhardy@hotmail.com
Study Contact Backup
- Name: Jean-François Brichant, PhD
- Phone Number: 00 32-4-3667180
- Email: jfbrichant@chuliege.be
Study Locations
-
-
Liege
-
Liège, Liege, Belgium, 4000
- Recruiting
- CHU de Liège
-
Contact:
- Jean Francois Brichant, MD, PhD
- Phone Number: 0032 43667180
- Email: jfbrichant@chuliege.be
-
Contact:
- Pierre-Yves Hardy, MD
- Phone Number: 003243667180
- Email: pyhardy@chuliege.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- •any patient scheduled for colorectal surgery within an ERP at CHU Liège
- Correct comprehension of french
Exclusion Criteria:
- •unable to answer the survey (cognitive disorders, bad knowledge of the French language)
- •closure of loop ileostomy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of Quality of recovery-15 (QoR-15) score between the preoperative scopre at Day 0 and postoperative score at Day 1 and its link between length of stay and occurrence of complication.
Time Frame: 2 weeks
|
The score of the Quality of recovery-15 (QoR-15) Survey and subscores.
The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-François Brichant, PhD, CHU de Liège
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-colorectal-QoR15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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