Clinical trial NCT01438268: TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes
Official title: Expedited Discharge of Patients Undergoing Pedicled TRAM Flap Breast Reconstruction Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Diseases
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
name: Ontario Ministry of Health and Long Term Care
First posted: 2011-09-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Reconstructive breast cancer patients

Brief 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.

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 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

Primary outcomes:
measure: The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
timeFrame: On average between 18 and 24 hours postoperatively
measure: The primary outcome measure is the quality of recovery post operatively, as assessed by the QoR27
timeFrame: on average between 48-72 hours postoperatively
measure: The primary outcome measure is the quality of recovery at discharge as assessed by the QoR27
timeFrame: On average 72-96 hours post operatively
measure: The primary outcome measure is the quality of recovery post operatively as assessed by the QoR27
timeFrame: On average 7-8 days postoperatively
Secondary outcomes:
measure: The secondary outcome measure is the quality of recovery as assessed by the VAS pain score
timeFrame: This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: John L Semple, MD, MSc, FRCSC, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Pamela J Morgan, MD, CCFP, FRCPC
role: STUDY_DIRECTOR
References: