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TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

W

Women's College Hospital

Status

Unknown

Conditions

Breast Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT01438268
2010-0050-E

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Reconstructive breast cancer patients
Description:
Patients having unilateral, bilateral immediate or delayed TRAM flaps who are discharged 18 hours postoperatively

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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