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

Mammaplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02791672
• Other study ID #: 20160216-01H
• Status: Not yet recruiting
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 2, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: May 2016
• Source: Ottawa Hospital Research Institute
• Contact: Michael J Stein, MD
• Phone: 6132864646
• Email: micstein[@]toh.on.ca
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mammaplasty

Intervention

Behavioral:
• Discharge within 24 hours
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion rate (from same-day discharge to in-patient care)		24 hours	No
Primary	Patient Satisfaction using Breast-Q questionnaire and Perioperative Care Patient		24 hours	No
Primary	Pain Score		24 hours	No
Primary	Amount of post-operative (24 hours) narcotic usage		24 hours	No
Secondary	Short and Long term complications		24 Hours	No
Secondary	Readmission Rate		24 Hours	No
Secondary	Cost Savings		24 Hours	No