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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04739605
Other study ID # 2021-colorectal-QoR15
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date May 1, 2022

Study information

Verified date June 2021
Source University of Liege
Contact Pierre-Yves Hardy, MD
Phone 00 32-4-3667180
Email pyhardy@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date May 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium CHU de Liege Liège Liege

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
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