Clinical trial NCT02791672: Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting
Official title: Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mammaplasty
Keywords: Perioperative Care
Breast Reconstruction
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Conversion rate (from same-day discharge to in-patient care)
timeFrame: 24 hours
measure: Patient Satisfaction using Breast-Q questionnaire and Perioperative Care Patient
timeFrame: 24 hours
measure: Pain Score
timeFrame: 24 hours
measure: Amount of post-operative (24 hours) narcotic usage
timeFrame: 24 hours
Secondary outcomes:
measure: Short and Long term complications
timeFrame: 24 Hours
measure: Readmission Rate
timeFrame: 24 Hours
measure: Cost Savings
timeFrame: 24 Hours
Other outcomes:
Locations:
Study officials:
References: