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NCT03461497 · ClinicalTrials.gov registry record
Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery
A clinical trial of Abdominal Surgery, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre.
- Active
- Registry status
- 530
- Enrollment target
- 7
- Study locations
NCT03461497: Active study of Abdominal Surgery, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre.
NCT03461497 is a study of Abdominal Surgery that is active but no longer recruiting, run by McGill University Health Centre/Research Institute of the McGill University Health Centre. The registered enrollment target is 530 participants. The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03461497, a study of Abdominal Surgery, is active but no longer recruiting, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre.
- ACTIVE NOT RECRUITING
- Registry status
- 530 participants
- Enrollment target
- 7
- Study locations
Study 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 perspectives and experiences into research and clinical decision-making. In abdominal surgery, this is currently precluded by the lack of PRO measures specifically developed and validated in the context of postoperative recovery. The core goal of this research project is to develop a PRO measure aimed to assess postoperative recovery from the perspective of patients undergoing abdominal surgery. This project complies with the US Food and Drug Administration (FDA) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for PRO development and will be conducted in three phases: Phase 1: Qualitative interviews with patients to develop a conceptual framework and generate relevant items. Phase 2: Use of Rasch Analysis for item-reduction and scale formation. Phase 3: Further assessment of measurement properties based on traditional psychometric methods.
Primary Outcome
PRO measure of recovery after abdominal surgery
Conditions Studied
Study Locations (7)
Other
- Hospital São Paulo - São Paulo
- Jewish General Hospital - Montreal
- San Raffaele Hospital - Milan
Florida
- Cleveland Clinic Florida - Weston
Ohio
- Cleveland Clinic (Main Campus) - Cleveland
Quebec
- Montreal General Hospital - Montreal
Hokkaido
- Hokkaido University Hospital - Sapporo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2016-07 |
| Est. Completion | 2026-07 |
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre9 total trials
What the registry record for NCT03461497 still lists
NCT03461497 is an observational study that tracks outcomes without assigning an intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Abdominal Surgery appearing as the primary indexed condition, and to 0 interventions.
NCT03461497 lists 7 locations in 5 states (Other, Florida, Ohio).
Frequently Asked Questions
What is clinical trial NCT03461497 about?
NCT03461497 is a clinical study titled "Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery". 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 perspectives and experiences into research and clinical decision-making. In abdominal surgery, this is cur...
What is the current status of trial NCT03461497?
This trial is currently active not recruiting. The enrollment target is 530 participants. The study started on 2016-07. Estimated completion is 2026-07.
What conditions does trial NCT03461497 study?
This clinical trial studies the following conditions: Abdominal Surgery.
Who is sponsoring clinical trial NCT03461497?
This trial is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03461497 being conducted?
This trial has 7 study locations across Florida, Ohio, Quebec, Hokkaido. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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