Postoperative Quality of RecoveryNCT04528524
Validation of the German Quality of Recovery-15 Questionnaire
An observational study of Postoperative Quality of Recovery, run by Marlene Fischer at 1 site in Germany.
Trial summary
The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective. It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Quality of Recovery
- What is being tested?
- Questionnaire
- How many people
- 186 participants
- Where
- 1 siteGermany
- Study dates
- 17 Aug 2020to 17 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective non-cardiac surgery under general anesthesia in a tertiary care hospital.
Who may be able to join
- elective non-cardiac surgery
- fluency in German
- general anesthesia
Who cannot join
- postoperative intensive care unit admission
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Quality of Recovery After General Anesthesia for Elective Non-cardiac Surgery - Validation of the German Translation of the Quality of Recovery-15 Questionnaire
The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective. It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state. The aim of this study is to validate a German version of the QoR-15 scale (QoR-15Dt) to measure postoperative recovery in German-speaking patients.
- Conditions
- Postoperative Quality of Recovery
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
QoR-15Dt
What is being measured
The primary outcome is the main question the study is designed to answer.
the German version of the QoR-15 questionnaire
Validity
Measured: first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start17 Aug 2020
- Primary completion17 Apr 2021
- Study completion17 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marlene Fischer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marlene Fischer, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528524
- Sponsor's protocol ID
- PACQoR1
- Status last verified
- Jun 2021
- First submitted
- 24 Aug 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery After General Anesthesia for Elective Non-cardiac Surgery - Validation of the German Translation of the Quality of Recovery-15 Questionnaire
- ClinicalTrials.gov ID
- NCT04528524
- Acronym / sponsor ID
- PACQoR1
- Conditions
- Postoperative Quality of Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Marlene FischerUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective. It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state. The aim of this study is to validate a German version of the QoR-15 scale (QoR-15Dt) to measure postoperative recovery in German-speaking patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective non-cardiac surgery under general anesthesia in a tertiary care hospital.
Key inclusion criteria (3 listed)
- elective non-cardiac surgery
- fluency in German
- general anesthesia
Key exclusion criteria (1 listed)
- postoperative intensive care unit admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQoR-15Dt | Other | – |
Primary outcome
the German version of the QoR-15 questionnaire
Time frame: first postoperative day
Validity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Quality of Recovery, run by Marlene Fischer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the German version of the QoR-15 questionnaire (time frame: first postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.