Evaluation of Short Scar Periareolar Inferior Pedicle Reduction Mammoplasty in Oncoplastic Breast SurgeryNCT06901180
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
An observational study of Evaluation of Short Scar Periareolar Inferior Pedicle Reduction Mammoplasty in Oncoplastic Breast Surgery, run by Sohag University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Evaluation of Short Scar Periareolar Inferior Pedicle Reduction Mammoplasty in Oncoplastic Breast Surgery
- What is being tested?
- short scar periareolar inferior pedicle reduction mammoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female patients aged from 25 years to 75 years with early breast cancer that meet inclusion and exclusion criteria
Who may be able to join
- 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.
Who cannot join
- 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.
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- cardiomyopathy
- connective tissue disorders with significant vasculitis.
- Previous chest wall or breast radiation.
- Patients' refusal participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Being tested
- short scar periareolar inferior pedicle reduction mammoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short scar periareolar inferior pedicle reduction mammoplastyProcedure or surgery
reduction mammoplasty that minimizes scar with better cosmetic outcomes
| Study group | Role | What they receive |
|---|---|---|
| short scar periareolar inferior pedicle reduction mammoplasty | oncoplastic reduction mammoplasty through peri-areolar incision Receives: Procedure: short scar periareolar inferior pedicle reduction mammoplasty | |
| wise pattern reduction mammoplasty | reduction mammoplasty through inverted T incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
oncological outcomes
detect incidence of local recurrence of malignancy
Measured: 1 year
post operative complications
surgical complications
Measured: 1 month
cosmetic outcomes
patients' satisfaction with their breast
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Short Scar Periareolar Inferior Pedicle Reduction Mammoplasty in Oncoplastic Breast SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gadelkarim Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901180
- Sponsor's protocol ID
- soh-med-25-3-2md
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short Scar Periareolar Inferior Pedicle Reduction Mammoplasty in Oncoplastic Breast Surgery
- ClinicalTrials.gov ID
- NCT06901180
- Acronym / sponsor ID
- soh-med-25-3-2md
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 28 Mar 2025 (actual)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short scar periareolar inferior pedicle reduction mammoplasty | – | Procedure: short scar periareolar inferior pedicle reduction mammoplastyoncoplastic reduction mammoplasty through peri-areolar incision |
| wise pattern reduction mammoplasty | – | –reduction mammoplasty through inverted T incision |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients aged from 25 years to 75 years with early breast cancer that meet inclusion and exclusion criteria
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients with a contraindication to breast conservative surgery:
- Previous chest wall or breast radiation.
- Patients' refusal participation.
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 |
|---|---|---|
| short scar periareolar inferior pedicle reduction mammoplastyreduction mammoplasty that minimizes scar with better cosmetic outcomes | Procedure or surgery | short scar periareolar inferior pedicle reduction mammoplasty |
Primary outcome
oncological outcomes
Time frame: 1 year
detect incidence of local recurrence of malignancy
post operative complications
Time frame: 1 month
surgical complications
cosmetic outcomes
Time frame: 1 year
patients' satisfaction with their breast
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of Short Scar Periareolar Inferior Pedicle Reduction Mammoplasty in Oncoplastic Breast Surgery, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed gadelkarim, ms (01121280177 ext. 02, ahmedgadalkreem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oncological outcomes (time frame: 1 year). The study lists 3 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 28 Mar 2025.