SurgeryNCT01902147
Postoperative Quality Recovery Scale (PQRS)
An observational study of Surgery and Recovery, run by Franco Carli at 1 site in Canada.
Trial summary
Recovery following general anesthesia and surgery is a complex issue confounded by the type of surgery, surgical care, inflammation, different anesthetic drugs and techniques, patient co-morbidities, and differing patient and clinician perceptions of what constitutes good recovery. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Postoperative Quality Recovery Scale (PQRS)
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Aug 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing elective major abdominal, thoracic, and arthroplasty surgery
Who may be able to join
- elective major abdominal, thoracic, and arthroplasty surgery
Who cannot join
- Poor comprehension of English or French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Recovery in Patients Undergoing Major Abdominal, Thoracic, and Arthroplasty Surgery Using an Enhanced Recovery Program.
Recovery following general anesthesia and surgery is a complex issue confounded by the type of surgery, surgical care, inflammation, different anesthetic drugs and techniques, patient co-morbidities, and differing patient and clinician perceptions of what constitutes good recovery. In this observational study, quality of recovery and patient satisfaction will be measured using the Postoperative Quality Recovery Scale (PQRS). This tool includes six domains of recovery: physiological, nociceptive (pain and nausea), emotive (anxiety and depression), functional recovery (return of activities of daily living), self-assessed recovery, and cognitive recovery.
- Being tested
- Postoperative Quality Recovery Scale (PQRS)
- Keywords
- abdominal, thoracic, arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Quality Recovery Scale (PQRS)Other
The PQRS is completed prior to surgery to provide baseline values, and then repeated at different intervals: 15 minutes, 40 minutes, 1 and 3 days, and 4-8 weeks after the completion of surgery. Recovery is broadly defined as return to baseline or better.
| Study group | Role | What they receive |
|---|---|---|
| Elective major abdominal, thoracic, and arthroplasty surgery | All consenting patients scheduled for elective major abdominal, thoracic, and arthroplasty surgery will be followed for 8 weeks after surgery to measure the quality of recovering using the PQRS. Receives: Other: Postoperative Quality Recovery Scale (PQRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recovery (return to baseline or better) in the cognitive domain of the PQRS
Measured: postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franco Carli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902147
- Sponsor's protocol ID
- 13-141-SDR
- Status last verified
- Sep 2015
- First submitted
- 15 Jul 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
PubMed 20601860
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Recovery in Patients Undergoing Major Abdominal, Thoracic, and Arthroplasty Surgery Using an Enhanced Recovery Program.
- ClinicalTrials.gov ID
- NCT01902147
- Acronym / sponsor ID
- 13-141-SDR
- Keywords
- abdominal, thoracic, arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Franco CarliUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Jul 2013 (estimated)
- 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.
Recovery following general anesthesia and surgery is a complex issue confounded by the type of surgery, surgical care, inflammation, different anesthetic drugs and techniques, patient co-morbidities, and differing patient and clinician perceptions of what constitutes good recovery. In this observational study, quality of recovery and patient satisfaction will be measured using the Postoperative Quality Recovery Scale (PQRS). This tool includes six domains of recovery: physiological, nociceptive (pain and nausea), emotive (anxiety and depression), functional recovery (return of activities of daily living), self-assessed recovery, and cognitive recovery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective major abdominal, thoracic, and arthroplasty surgery | – | Other: Postoperative Quality Recovery Scale (PQRS)All consenting patients scheduled for elective major abdominal, thoracic, and arthroplasty surgery will be followed for 8 weeks after surgery to measure the quality of recovering using the PQRS. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing elective major abdominal, thoracic, and arthroplasty surgery
Key inclusion criteria (1 listed)
- elective major abdominal, thoracic, and arthroplasty surgery
Key exclusion criteria (1 listed)
- Poor comprehension of English or French
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 |
|---|---|---|
| Postoperative Quality Recovery Scale (PQRS)The PQRS is completed prior to surgery to provide baseline values, and then repeated at different intervals: 15 minutes, 40 minutes, 1 and 3 days, and 4-8 weeks after the completion of surgery. Recovery is broadly defined as return to baseline or better. | Other | Elective major abdominal, thoracic, and arthroplasty surgery |
Primary outcome
Incidence of recovery (return to baseline or better) in the cognitive domain of the PQRS
Time frame: postoperative day 3
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 23 Sep 2015.
- Background: PubMed 20601860Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
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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.
Franco Carli, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
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 Surgery and Recovery, run by Franco Carli at 1 site in Canada.
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 1 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 23 Sep 2015. 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 Canada. 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?
Incidence of recovery (return to baseline or better) in the cognitive domain of the PQRS (time frame: postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902147, which also lists 1 linked publication.
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 23 Sep 2015.