Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting

June 2, 2016 updated by: Jing Zhang, Ottawa Hospital Research Institute

The pedicled latissimus dorsi flap is a piece of tissue taken from the back that is used to reconstruct the breast after cancerous tissue is removed. Over the years, improvements in surgical technique and pain control have decreased the length of stay in hospital after this procedure. Recently, early discharge after breast reconstruction using another very similar pedicled flap, called the transverse rectus abdominis flap, was shown to be safe, patient-centered, and associated with significant hospital cost-savings by another Canadian group.

With increasing pressure from hospital administrators to weigh financial considerations into treatment decision making, doctors must test cost-saving strategies in order to ensure patient satisfaction and safety. Here, we plan to evaluate patient safety, satisfaction and cost efficacy in breast reconstruction using the pedicled latissimus dorsi myocutaneous flap.

We hypothesize that patient care planning can allow for safe and cost-effective same-day discharge and improved patient satisfaction after autologous breast reconstruction using the pedicled latissimus dorsi flap. After nearly 10 successful same-day discharges using this flap, our experience at the Ottawa Hospital suggests that this practice is safe, has increased patient satisfaction scores, decreased narcotic use, no short or long term complications and is more cost effective compared to patients who stay overnight.

In the present study, we hope to quantify our results by demonstrating that same day discharge is a cost effective strategy that does not compromise patient safety and satisfaction.

Study Overview

Status

Unknown

Conditions

Detailed Description

The pedicled latissimus dorsi myocutaneous flap is a reliable option for autologous breast reconstruction after mastectomy. Improvements in technique and postoperative analgesia have decreased the length of hospital stay required after this procedure. Early discharge following a range of procedures has been consistently shown to increase patient satisfaction, decrease perioperative complication rates, and improve hospital cost-effectiveness. Specifically, early discharge after breast reconstruction using another pedicled myocutaneous flap, the transverse rectus abdominis myocutaneous flap, was shown to be safe, patient-centered, and associated with significant hospital cost-savings by another Canadian group.

The balance between financial savings and patient safety/comfort has been studied vigorously across many medical disciplines. With increasing pressure from hospital administrators to weigh financial considerations into treatment decision making, clinicians must empirically test cost-saving strategies in order to ensure patient satisfaction and safety.

Here, we evaluate patient safety, satisfaction and cost efficacy in ambulatory breast reconstruction using the pedicled latissimus dorsi myocutaneous flap.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Study population will be females older than 18 years old who undergo breast reconstructive surgery with the Latissimus Dorsi flap.

Description

Inclusion Criteria:

  • All patients who undergo breast reconstruction using the latissimus dorsi myocutaneous flap.

Exclusion Criteria:

  • All patients undergoing breast reconstruction without the latissimus dorsi flap.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Same Day Discharge
Following a Latissimus Dorsi flap reconstruction patients will be offered discharge at 24 hours. Patients successfully discharged within 24 hours of their surgery will be included in the cohort group.
If both the physician and patient have no concerns within 24 hours of a Latissimus Dorsi Flap breast reconstruction the patient will be discharged home and enrolled in the cohort group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Conversion rate (from same-day discharge to in-patient care)
Time Frame: 24 hours
24 hours
Patient Satisfaction using Breast-Q questionnaire and Perioperative Care Patient
Time Frame: 24 hours
24 hours
Pain Score
Time Frame: 24 hours
24 hours
Amount of post-operative (24 hours) narcotic usage
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Short and Long term complications
Time Frame: 24 Hours
24 Hours
Readmission Rate
Time Frame: 24 Hours
24 Hours
Cost Savings
Time Frame: 24 Hours
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (ESTIMATE)

June 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 20160216-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will not be made available. Anonymity will be maintained for all published data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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