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TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

NCT01438268 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2013-11-19

No results posted yet for this study

Summary

Specific Aim: To assess the quality of recovery of patients following early discharge (18 hrs) after pedicled TRAM flap breast reconstruction. Quality of recovery will be assessed using a 27-item validated questionnaire, QoR-27 at discharge, and on Post Operative Days (POD) 2, 4 and 7. In addition a 100 mm Visual Analog Score (VAS) for Pain will be completed on discharge from the recovery room, discharge from hospital and on POD 2, 4 and 7.

Clinical Relevance: Postoperative recovery is a complex process related to various outcomes such as physiological endpoints, incidence of adverse events and change in psychological status. Previous studies of recovery after surgery and anesthesia have focused primarily on the physiological endpoints and the incidence of adverse events. Much of the work has occurred in specialties dealing with chronic disease states such as cancer, rheumatology and musculoskeletal disorders. There is clearly a need to focus on recovery outcome measures in the ambulatory population for postoperative recovery. Here the investigators propose to measure postoperative recovery outcomes within the first week following a TRAM flap reconstructive procedure using a validated postoperative quality of recovery instrument (QoR-27) and a 100 mm VAS for pain.

Conditions

  • Breast Diseases

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • John L Semple, MD, MSc, FRCSC, FACS · Women's College Hospital

  • Pamela J Morgan, MD, CCFP, FRCPC · Women's College Hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-08-31
Completion
2014-01-31

Countries

  • Canada

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 NCT01438268 on ClinicalTrials.gov