NCT03578068

Brief Summary

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.

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 May 2018

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

Study Start

First participant enrolled

May 1, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

July 5, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

May 28, 2018

Last Update Submit

June 22, 2018

Conditions

Keywords

Quality of RecoveryPostoperativeSurgeryFrenchTranslationValidation

Outcome Measures

Primary Outcomes (1)

  • 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

    the score is calculated from the questionnaire 24 hours after the surgery

    24h after surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service D'Anesthesiologie - Reanimation Chirurgicale

Strasbourg, 67098, France

RECRUITING

Related Publications (1)

  • Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.

Study Officials

  • Eric Noll, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

July 5, 2018

Study Start

May 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

July 5, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations