- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06783179
Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Postoperative Outcomes and Patient Satisfaction for Patients Admitted to the Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.
OUTLINE: This is an observational study.
Patients have their medical records reviewed and may complete a survey on study.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Contact Backup
- Name: Maurician Buchanan
- Email: Buchanan.Mauricia@mayo.edu
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Recruiting
- Mayo Clinic in Florida
-
Contact:
- Mauricia Buchanan
- Email: Buchanan.Mauricia@mayo.edu
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Brian D. Rinker, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis followed by immediate tissue expander reconstruction who are either admitted to the Care Hotel post operatively, discharge home or admitted to the hospital.
Exclusion Criteria:
- Younger than 18 years old.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational
Patients have their medical records reviewed and may complete a survey on study.
|
Non-interventional study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications
Time Frame: Up to 30 days
|
Recorded as incidence of hematoma, infection, readmission, and/or reoperation within 30 days of initial procedure.
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: Up to 30 days
|
Assessed via voluntary survey given at first routine post operative visit to all patients who were admitted to the Care Hotel.
The survey consists of 5 questions related to the Care Hotel Stay and one question related to pain level during the stay..
The 5 questions are answered on a scale ranging from 1-5 where 1=strongly disagree and 5=strongly agree, and the final questions is answered on a scale of 1-10 where 1=little pain and 10=worst pain ever experienced.
There are also free-text sections for participants to indicate anything that impressed them about their experience with Care Hotel and/or anytihng that disappointed them about their experience.
|
Up to 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian D. Rinker, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-006876 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2024-10631 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
product manufactured in and exported from the U.S.
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