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

NCT02791672 | Unknown DMC

• 1 other identifier: 20160216-01H
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mammaplasty

Keywords

Perioperative Care; Breast Reconstruction

Outcome Measures

Primary Outcomes (4)

• Conversion rate (from same-day discharge to in-patient care)

  24 hours

• Patient Satisfaction using Breast-Q questionnaire and Perioperative Care Patient

  24 hours

• Pain Score

  24 hours

• Amount of post-operative (24 hours) narcotic usage

  24 hours

Secondary Outcomes (3)

• Short and Long term complications

  24 Hours

• Readmission Rate

  24 Hours

• Cost Savings

  24 Hours

Study Arms (1)

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.

Behavioral: Discharge within 24 hours

Interventions

Discharge within 24 hours BEHAVIORAL

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.

Same Day Discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Central Study Contacts

Michael J Stein, MD

CONTACT

6132864646; micstein@toh.on.ca

Jing Zhang, MD

CONTACT

jingzhang2013@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Plastic Surgeon

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 7, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 7, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share