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TRAM Procedure in Ambulatory Surgical Facility: Quality of Recovery Outcomes

NCT ID: NCT01438268

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Breast Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Reconstructive breast cancer patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role collaborator

Women's College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John L Semple, MD, MSc, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Pamela J Morgan, MD, CCFP, FRCPC

Role: STUDY_DIRECTOR

Women's College Hospital

Locations

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Women's College Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2010-0050-E

Identifier Type: -

Identifier Source: org_study_id