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ACTIVE NOT RECRUITING

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

NCT03461497 · View on ClinicalTrials.gov ↗

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 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

FieldValue
Enrollment Target 530 participants
Start Date 2016-07
Est. Completion 2026-07

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03461497

The ClinicalTrials.gov registry entry for NCT03461497 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McGill University Health Centre/Research Institute of the McGill University Health Centre, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Abdominal Surgery appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03461497 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Other, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial