MammaplastyNCT02791672
Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting
An observational study of Mammaplasty, run by Ottawa Hospital Research Institute.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mammaplasty
- What is being tested?
- Discharge within 24 hours
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be females older than 18 years old who undergo breast reconstructive surgery with the Latissimus Dorsi flap.
Who may be able to join
- All patients who undergo breast reconstruction using the latissimus dorsi myocutaneous flap.
Who cannot join
- All patients undergoing breast reconstruction without the latissimus dorsi flap.
Trial locations and contacts
No sites are listed yet.
Jing Zhang, MD contact
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Mammaplasty
- Being tested
- Discharge within 24 hours
- Keywords
- Perioperative Care, Breast Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge within 24 hoursBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Discharge within 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate (from same-day discharge to in-patient care)
Measured: 24 hours
Patient Satisfaction using Breast-Q questionnaire and Perioperative Care Patient
Measured: 24 hours
Pain Score
Measured: 24 hours
Amount of post-operative (24 hours) narcotic usage
Measured: 24 hours
Secondary outcomes (3)
Short and Long term complications
Measured: 24 Hours
Readmission Rate
Measured: 24 Hours
Cost Savings
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Zhang, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791672
- Sponsor's protocol ID
- 20160216-01H
- Status last verified
- May 2016
- First submitted
- 31 May 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data will not be made available. Anonymity will be maintained for all published data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting
- ClinicalTrials.gov ID
- NCT02791672
- Acronym / sponsor ID
- 20160216-01H
- Conditions
- Mammaplasty
- Keywords
- Perioperative Care, Breast Reconstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Same Day Discharge | – | Behavioral: Discharge within 24 hoursFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be females older than 18 years old who undergo breast reconstructive surgery with the Latissimus Dorsi flap.
Key inclusion criteria (1 listed)
- All patients who undergo breast reconstruction using the latissimus dorsi myocutaneous flap.
Key exclusion criteria (1 listed)
- All patients undergoing breast reconstruction without the latissimus dorsi flap.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discharge within 24 hoursIf 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. | Behavioural | Same Day Discharge |
Primary outcome
Conversion rate (from same-day discharge to in-patient care)
Time frame: 24 hours
Patient Satisfaction using Breast-Q questionnaire and Perioperative Care Patient
Time frame: 24 hours
Pain Score
Time frame: 24 hours
Amount of post-operative (24 hours) narcotic usage
Time frame: 24 hours
3 secondary outcomes
Short and Long term complications
Time frame: 24 Hours
Readmission Rate
Time frame: 24 Hours
Cost Savings
Time frame: 24 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Individual participant dataSharing planned: Yes. Individual participant data will not be made available. Anonymity will be maintained for all published data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Zhang, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Mammaplasty, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J Stein, MD (6132864646, micstein@toh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (from same-day discharge to in-patient care) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.