TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

NCT01438268 | Unknown

• 1 other identifier: 2010-0050-E
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (1)

• The secondary outcome measure is the quality of recovery as assessed by the VAS pain score

  This outcome will be done at the exact same time as the measurements of Quality of Recovery listed above

Study Arms (1)

Reconstructive breast cancer patients

Patients having unilateral, bilateral immediate or delayed TRAM flaps who are discharged 18 hours postoperatively

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Reconstructive breast cancer patients

You may qualify if:

• Women undergoing any type of TRAM flap
• Age\<75 yrs
• Non-smoker

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John L Semple, MD, MSc, FRCSC, FACS

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

• Pamela J Morgan, MD, CCFP, FRCPC

  Women's College Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: September 22, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2014
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

CA (1)