- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06901180
In Our Study We Compare Results of Two Oncoplastic Breast Surgery (short Scar Reduction Mammoplasty and Wise Pattern Reduction Mammoplasty) As Surgical Treatment of Breast Cancer
March 22, 2025 updated by: Ahmed Gadelkarim Mohamed, Sohag University
Evaluation of Short Scar Periareolar Inferior Pedicle Reduction Mammoplasty in Oncoplastic Breast Surgery
in our study we compare results of two oncoplastic breast surgery (short scar reduction mammoplasty and wise pattern reduction mammoplasty) as surgical treatment of breast cancer
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ahmed gadelkarim, ms
- Phone Number: 02 01121280177
- Email: ahmedgadalkreem@gmail.com
Study Locations
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-
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Sohag, Egypt, 82524
- Sohag University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
female patients aged from 25 years to 75 years with early breast cancer that meet inclusion and exclusion criteria
Description
Inclusion Criteria:
- Female patients with ages ranging from 25 to 75 years.
- Patients with operable breast cancer (Stage I, II and IIIa).
- Patients with moderate to large /ptotic breasts.
Exclusion Criteria:
Patients with a contraindication to breast conservative surgery:
- Multi-centric disease that can't be incorporated by local excision through a single incision that achieves adequate safety margin and satisfactory cosmetic results.
- inflammatory carcinoma.
- Contraindications to postoperative radiation e.g. pregnancy, pre-existing lung disease with reduced diffusing capacity and pulmonary TB.
- diffuse suspicious malignant micro-calcification on mammography.
- inability to attain negative surgical margins.
- cardiomyopathy
- connective tissue disorders with significant vasculitis.
- Previous chest wall or breast radiation.
- Patients' refusal participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
short scar periareolar inferior pedicle reduction mammoplasty
oncoplastic reduction mammoplasty through peri-areolar incision
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reduction mammoplasty that minimizes scar with better cosmetic outcomes
|
|
wise pattern reduction mammoplasty
reduction mammoplasty through inverted T incision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oncological outcomes
Time Frame: 1 year
|
detect incidence of local recurrence of malignancy
|
1 year
|
|
post operative complications
Time Frame: 1 month
|
surgical complications
|
1 month
|
|
cosmetic outcomes
Time Frame: 1 year
|
patients' satisfaction with their breast
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
March 17, 2025
First Submitted That Met QC Criteria
March 22, 2025
First Posted (Actual)
March 28, 2025
Study Record Updates
Last Update Posted (Actual)
March 28, 2025
Last Update Submitted That Met QC Criteria
March 22, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- soh-med-25-3-2md
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on short scar periareolar inferior pedicle reduction mammoplasty
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McMaster UniversityCanadian Society of Plastic SurgeonsCompleted
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Kafrelsheikh UniversityUnknownTo Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated FactorsEgypt