Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quality of Recovery Using QoR-15 in Enhanced Recovery After Colorectal Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04739605
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Jean François Brichant, University of Liege

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery within an enhanced recovery program 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 score at the subsections will be correlated with the medical and surgical characteristics of the patients.

Condition or disease
Colorectal Surgery Patient-related Outcomes Measures Enhanced Recovery After Surgery

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Postoperative Patient-reported Quality of Recovery in Colorectal Surgery Patients Under Enhanced Recovery After Surgery Program Using QoR-15.
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : May 1, 2022
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any patient schedules for colorectal surgery with the ERP at CHU Liège (Belgium). Patients age must be greater than 18 years. There is no maximum limit of age.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739605


Contacts
Layout table for location contacts
Contact: Pierre-Yves Hardy, MD 00 32-4-3667180 pyhardy@hotmail.com
Contact: Jean-François Brichant, PhD 00 32-4-3667180 jfbrichant@chuliege.be

Locations
Layout table for location information
Belgium
CHU de Liege Recruiting
Liège, Liege, Belgium, 4000
Contact: Jean Francois Brichant, MD, PhD    0032 43667180    jfbrichant@chuliege.be   
Contact: Pierre-Yves Hardy, MD    003243667180    pyhardy@chuliege.be   
Sponsors and Collaborators
University of Liege
Investigators
Layout table for investigator information
Principal Investigator: Jean-François Brichant, PhD CHU de Liège
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jean François Brichant, Head of the Anesthesiology department, University of Liege
ClinicalTrials.gov Identifier: NCT04739605    
Other Study ID Numbers: 2021-colorectal-QoR15
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean François Brichant, University of Liege:
colorectal
enhanced recovery
patient-related outcomes measures
QoR15