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Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery

NCT03461497 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 530

Last updated 2025-04-13

No results posted yet for this 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.

Conditions

  • Abdominal Surgery

Sponsors & Collaborators

  • Hospital São Paulo, Brazil

    collaborator UNKNOWN

  • Hokkaido University Hospital

    collaborator OTHER

  • San Raffaele University Hospital, Italy

    collaborator OTHER

  • Cleveland Clinic Florida

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Jewish General Hospital

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Julio F Fiore Jr, PhD · McGill University, Department of Surgery

  • Liane S Feldman, MD · McGill University, Department of Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States
  • Brazil
  • Canada
  • Italy
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461497 on ClinicalTrials.gov