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

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02791672
Collaborator
(none)
40
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Discharge within 24 hours

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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Conversion rate (from same-day discharge to in-patient care) [24 hours]

  2. Patient Satisfaction using Breast-Q questionnaire and Perioperative Care Patient [24 hours]

  3. Pain Score [24 hours]

  4. Amount of post-operative (24 hours) narcotic usage [24 hours]

Secondary Outcome Measures

  1. Short and Long term complications [24 Hours]

  2. Readmission Rate [24 Hours]

  3. Cost Savings [24 Hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ottawa Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jing Zhang, Staff Plastic Surgeon, University of Ottawa
ClinicalTrials.gov Identifier:
NCT02791672
Other Study ID Numbers:
  • 20160216-01H
First Posted:
Jun 7, 2016
Last Update Posted:
Jun 7, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Jing Zhang, Staff Plastic Surgeon, University of Ottawa

Study Results

No Results Posted as of Jun 7, 2016