TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

Breast Diseases Clinical Trial

— TRAM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01438268
• Other study ID #: 2010-0050-E
• Status: Active, not recruiting
• Phase: N/A
• First received: June 21, 2011
• Last updated: November 15, 2013
• Start date: July 2011
• Est. completion date: January 2014

Study information

• Verified date: November 2013
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Diseases

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Women's College Hospital	Ontario Ministry of Health and Long Term Care, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No