NCT04739605

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

February 3, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

February 3, 2021

Last Update Submit

June 21, 2021

Conditions

Colorectal SurgeryPatient-related Outcomes MeasuresEnhanced Recovery After Surgery

Keywords

colorectalenhanced recoverypatient-related outcomes measuresQoR15

Outcome Measures

Primary Outcomes (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.

    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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • any patient scheduled for colorectal surgery within an ERP at CHU Liège
  • Correct comprehension of french

You may not qualify if:

  • unable to answer the survey (cognitive disorders, bad knowledge of the French language)
  • closure of loop ileostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liege

Liège, Liege, 4000, Belgium

RECRUITING

Study Officials

  • Jean-François Brichant, PhD

    Centre Hospitalier Universitaire de Liege

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Yves Hardy, MD

CONTACT

00 32-4-3667180pyhardy@hotmail.com

Jean-François Brichant, PhD

CONTACT

00 32-4-3667180jfbrichant@chuliege.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Anesthesiology department

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 4, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

June 23, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)