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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03578068
Other study ID # 7051
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date August 2019

Study information

Verified date May 2018
Source University Hospital, Strasbourg, France
Contact Eric Noll, MD
Phone 33 3 88 55 23 37
Email eric.noll@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service D'Anesthesiologie - Reanimation Chirurgicale Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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