Status:
ACTIVE_NOT_RECRUITING
Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Hospital São Paulo, Brazil
Hokkaido University Hospital
Conditions:
Abdominal Surgery
Eligibility:
All Genders
18+ years
Brief Summary
As surgery enters the era of value-based care, it is advocated that postoperative recovery be measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the patient's perspe...
Detailed Description
OBJECTIVE: To develop a comprehensive, conceptually relevant and psychometrically sound PRO measure to assess recovery after abdominal surgery. OUTLINE: * Phase 1(Conceptual framework and item gene...
Eligibility Criteria
Inclusion
- The following applies to all phases of the project.
- Age ≥18 years old
- Abdominal surgery within three days to three months before enrolment
- Fluent in the local language
- Willing and able to provide written informed consent
Exclusion
- Documented mental impairment
- Palliative care
- Advanced musculoskeletal, neurological, pulmonary or cardiac disorders
- Organ transplantation
- Cesarean section
Key Trial Info
Start Date :
July 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT03461497
Start Date
July 1 2016
End Date
July 1 2026
Last Update
April 13 2025
Active Locations (7)
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1
Cleveland Clinic Florida
Weston, Florida, United States
2
Cleveland Clinic (Main Campus)
Cleveland, Ohio, United States
3
Hospital São Paulo
São Paulo, Brazil, 04024-002
4
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4