TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes (TRAM)

Expedited Discharge of Patients Undergoing Pedicled TRAM Flap Breast Reconstruction Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

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.

Study Overview

• Status: Unknown
• Conditions: Breast Diseases

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Reconstructive breast cancer patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Reconstructive breast cancer patients; Patients having unilateral, bilateral immediate or delayed TRAM flaps who are discharged 18 hours postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27	The patient will be contacted by the study coordinator, 4 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)	On average 72-96 hours post operatively
The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27	The patient will be contacted by the study coordinator, 7 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)	On average 7-8 days postoperatively
The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27	The patient will be met with by the study coordinator, just before discharge to administer the Quality of Recovery Questionnaire (QoR27)	On average between 18 and 24 hours postoperatively
The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27	The patient will be contacted by the study coordinator, 2 days following their surgery to administer the Quality of Recovery Questionnaire (QoR27)	on average between 48-72 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome measure is the quality of recovery as assessed by the VAS pain score	These scores will be compared	This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: Ontario Ministry of Health and Long Term Care; The Physicians' Services Incorporated Foundation
• 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

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: 2010-0050-E