Oncoplastic Surgery Outcomes Database
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTufts Medical Center
About this trial
This is a retrospective and prospective chart review of surgical outcomes and collecting patient satisfaction outcomes using validated surveys for oncoplastic breast surgery and Goldilocks mastectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biological females >= 18 years old requiring oncologic breast surgery with and without reconstruction at Tufts Medicine.
Disqualifiers
Biological females < 18 years old
Trial population
Patients of Tufts Medicine hospitals requiring oncologic breast surgery with and without reconstruction.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Oncoplastic Breast Surgery
Procedure/SurgeryBreast conservation surgery incorporating an oncologic partial mastectomy with ipsilateral defect repair using volume displacement or volume replacement techniques with contralateral symmetry surgery as appropriate
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Cancer Stage
The TNM system of cancer classification determines the stage of cancer based on type of cancer, size of cancer, lymph node status, presence of metastasis
Time frame
From enrollment to up to 1 month after surgery.2
Patient Satisfaction
Measured using validated surveys pre-operative and post-operative (2 week, 6 month, 1 year).
Time frame
From enrollment to 1 year after surgery.3
Cancer Recurrence
Recurrence of cancer following surgery and adjuvant therapy
Time frame
From enrollment to 20 years after surgerySecondary outcomes
1
Positive Margin Rate
The investigators will measure rates of positive margins after cancer resection that requires additional resection.
Time frame
From enrollment to 1 year after initial surgery2
Surgical Complication Rate
Complications from surgery (infection, wound dehiscence, seroma, hematoma, etc.) will be measured and aggregated into a overall rate of major complications (requires intervention) and minor complications as percentages.
Time frame
From date of surgery up to 5 years after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov