NCT01902147

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

July 15, 2013

Last Update Submit

September 21, 2015

Conditions

Keywords

abdominalthoracicarthroplasty

Outcome Measures

Primary Outcomes (1)

  • Incidence of recovery (return to baseline or better) in the cognitive domain of the PQRS

    postoperative day 3

Study Arms (1)

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.

Other: Postoperative Quality Recovery Scale (PQRS)

Interventions

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.

Elective major abdominal, thoracic, and arthroplasty surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective major abdominal, thoracic, and arthroplasty surgery

You may qualify if:

  • elective major abdominal, thoracic, and arthroplasty surgery

You may not qualify if:

  • Poor comprehension of English or French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 20601860BACKGROUND

Study Officials

  • Franco Carli, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Anesthesia

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 18, 2013

Study Start

November 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations