TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes — TRAM  

Breast Diseases Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Diseases

• NCT number: NCT01438268
• Study type: Observational
• Source: Women's College Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2011
• Completion date: January 2014