TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT01438268
First received: June 21, 2011
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.


Condition
Breast Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expedited Discharge of Patients Undergoing Pedicled TRAM Flap Breast Reconstruction Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

Resource links provided by NLM:


Further study details as provided by Women's College Hospital:

Primary Outcome Measures:
  • The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27 [ Time Frame: On average between 18 and 24 hours postoperatively ] [ Designated as safety issue: No ]
    The patient will be met with by the study coordinator, just before discharge to administer the Quality of Recovery Questionnaire (QoR27)

  • The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27 [ Time Frame: on average between 48-72 hours postoperatively ] [ Designated as safety issue: No ]
    The patient will be contacted by the study coordinator, 2 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)

  • The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27 [ Time Frame: On average 72-96 hours post operatively ] [ Designated as safety issue: No ]
    The patient will be contacted by the study coordinator, 4 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)

  • The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27 [ Time Frame: On average 7-8 days postoperatively ] [ Designated as safety issue: No ]
    The patient will be contacted by the study coordinator, 7 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)


Secondary Outcome Measures:
  • The secondary outcome measure is the quality of recovery as assessed by the VAS pain score [ Time Frame: This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above ] [ Designated as safety issue: No ]
    These scores will be compared


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Reconstructive breast cancer patients
Patients having unilateral, bilateral immediate or delayed TRAM flaps who are discharged 18 hours postoperatively

Detailed Description:

Women's College Hospital is the first and only independent ambulatory care hospital in Ontario, and the only hospital in Ontario with a primary focus on women's health. Patients undergoing breast reconstruction following breast cancer at our institution are now undergoing expedited discharge at 18 hrs postoperatively. To facilitate next day discharge, a multidisciplinary group was formed to determine the best evidence for perioperative care to ensure patient safety and excellent postoperative recovery. Minimizing length of stay has obvious cost savings for hospitals, but for patients the advantages include minimizing exposure to hospital-acquired infections and an earlier return to their more familiar home environment. The need to balance the advantage of early discharge to patient complications, however, must be addressed. As other hospitals across the country face the same length of stay constraints as has been our experience, this study will provide important data on the quality of recovery of patients undergoing early discharge following breast reconstructive surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Reconstructive breast cancer patients

Criteria

Inclusion Criteria:

  • Women undergoing any type of TRAM flap
  • Age<75 yrs
  • Non-smoker

Exclusion Criteria:

  • History of chronic pain or psychiatric disturbance
  • History of chronic use of opioid medications
  • Allergy to local anesthesia or opioid medication
  • Inability to communicate in English
  • BMI>35
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438268

Locations
Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
The Physicians' Services Incorporated Foundation
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: John L Semple, MD, MSc, FRCSC, FACS Women's College Hospital
Study Director: Pamela J Morgan, MD, CCFP, FRCPC Women's College Hospital
  More Information

No publications provided

Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT01438268     History of Changes
Other Study ID Numbers: 2010-0050-E
Study First Received: June 21, 2011
Last Updated: November 15, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 14, 2014