Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15 (QoR-15F)

June 22, 2018 updated by: University Hospital, Strasbourg, France
After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, […], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67098
        • Recruiting
        • Service D'Anesthesiologie - Reanimation Chirurgicale
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric NOLL, MD
        • Sub-Investigator:
          • François DEMUMIEUX, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery
  • Patient agreeing to use his data for research purposes

Exclusion Criteria:

  • Patient operated on a surgery for which it is highly probable that the postoperative management does not allow him to propose the completion of the J1 questionnaire
  • Patient unable to express non-opposition to participation in the study
  • Patient expressing opposition to participating in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
QoR-15F score Title: QoR-15F score Description: Time Frame: 24h befor surgery Outcome 2 Title: QoR-15F score Description: Time Frame: 24h after surgery
Time Frame: 24h after surgery
the score is calculated from the questionnaire 24 hours after the surgery
24h after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Eric Noll, MD, University Hospital, Strasbourg, france

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

June 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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