Breast Cancer Early Stage Breast Cancer (Stage 1-3)SLIMNCT07022509
Matrix Rotation Flap Versus Single Incision Lateral Sulcus Mammoplasty
A study testing proceduder surgery and Technique surgery in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Batterjee Medical College at 1 site in Egypt.
Trial summary
The study seeks to compare the single-incision lateral mammoplasty technique with the matrix rotation flap in patients with breast carcinoma. The primary outcome assessed is postoperative complications, while secondary outcomes include cosmetic appearance and patient satisfaction. Read more about this study
- Who is it for?
- Ages 42 to 61 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- proceduder surgery and Technique surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2022to 1 Jun 2024
- Phase
- Interventional
- 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 42 to 61 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Upper Quadrant Breast Carcinomas.
Who cannot join
- Patients with T4 tumors, inflammatory breast cancer and distant metastasis, multi-centric breast cancer in more than one quadrant and diffuse microcalcifications were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Benha University, Benha, Egypt
Giza, Cairo Governorate, 13511
About this study
Official title: Outcome Of Matrix Rotation Versus Single Incision Lateral Sulcus Mammoplasty In The Upper Quadrant Breast Carcinomas
The study seeks to compare the single-incision lateral mammoplasty technique with the matrix rotation flap in patients with breast carcinoma. The primary outcome assessed is postoperative complications, while secondary outcomes include cosmetic appearance and patient satisfaction.
Read the detailed description
This study is designed to conduct a comprehensive comparison between two breast-conserving surgical techniques used in the treatment of breast carcinoma: the single-incision lateral mammoplasty and the matrix rotation flap. These procedures are employed to achieve both oncologic safety and aesthetic preservation in patients undergoing surgery for breast cancer.
The primary objective of the study is to evaluate and compare the incidence and nature of postoperative complications associated with each technique. This includes, but is not limited to, wound healing issues, infection rates, hematoma or seroma formation, and any need for reoperation.
Secondary objectives focus on assessing the cosmetic outcomes and the overall satisfaction of the patients post-surgery. Cosmetic evaluation will be conducted through both surgeon-assessed and patient-reported outcomes, utilizing standardized scoring systems and photographic documentation. Patient satisfaction will be measured through validated questionnaires designed to capture perceptions of body image, aesthetic results, and quality of life following the procedure.
By systematically analyzing these parameters, the study aims to determine which technique offers a more favorable balance of surgical safety, aesthetic quality, and patient satisfaction, thereby guiding clinical decision-making in breast-conserving surgery for breast carcinoma.
- Being tested
- proceduder surgery, Technique surgery
- Keywords
- breast cancer, Oncology, MRF, SLIM
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proceduder surgeryOther
The single-incision lateral sulcus mammoplasty is a breast-conserving surgical technique that involves making a single incision along the lateral aspect of the inframammary fold or within the natural skin crease of the lateral sulcus. This approach provides direct access to the lateral quadrants of the breast, which are commonly affected in breast carcinoma, allowing for effective tumor excision while preserving the breast contour.
In SILSM, the incision is carefully planned to align with natural anatomical lines, ensuring optimal cosmetic results and minimal visible scarring. Through this lateral access point, the surgeon performs both tumor resection and glandular reshaping. The technique often involves mobilization and rearrangement of the remaining breast tissue to fill the defect left by the tumor excision, thereby maintaining breast symmetry and volume.
This techn
Technique surgeryOther
The matrix rotation flap is a versatile oncoplastic surgical technique employed in the reconstruction of partial breast defects following tumor excision. This method involves the creation of a rotational skin and glandular flap, mobilized from adjacent breast tissue, typically using an inferolateral or inferomedial pedicle. The flap is designed in a curvilinear or semicircular fashion, allowing it to rotate into the defect site while maintaining adequate vascular supply.
The MRF technique is particularly useful for defects in the lower quadrants of the breast, where direct tissue advancement may be limited. The surgeon carefully outlines a skin paddle adjacent to the resection cavity and undermines the surrounding breast parenchyma. The flap is then rotated and inset into the tumor bed to fill the defect, with the skin paddle contributing to both volume replacement and skin resurfacing if required.
This approach provides robust coverage of the surgical cavity, helps restore breast co
| Study group | Role | What they receive |
|---|---|---|
| Group MRF | Experimental | Matrix rotation flap MRF surgical procedure Receives: Other: Technique surgery |
| Group SLIM | Experimental | Single Incision Lateral Sulcus Mammoplasty (SLIM). Receives: Other: proceduder surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
The total number (percentage) of participants in each group who got post-operative complications such as wound infection, hematoma, and seroma.
Measured: 4 weeks
Secondary outcomes (2)
Asthetic outcomes
Vancouver's scar scale with ranges from 0 (normal skin) to 13 (worst scar possible)
Measured: 6 months
Patients' satisfaction
Five-point Likert scale with one being excellent, two good, three fair, four poor, and five bad. The higher the score, the worse is the result.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start7 May 2022
- Primary completion17 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Ragaa Abdelraouf Ibrahim, Batterjee Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022509
- Sponsor's protocol ID
- RC 9-4-2022
- Other IDs
- PNURSP2025R168
- Acronym
- SLIM
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be available upon approval of the funding institute
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.
PubMed 30620402
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Of Matrix Rotation Versus Single Incision Lateral Sulcus Mammoplasty In The Upper Quadrant Breast Carcinomas
- ClinicalTrials.gov ID
- NCT07022509
- Acronym / sponsor ID
- SLIM / RC 9-4-2022
- Keywords
- breast cancer, Oncology, MRF, SLIM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- 17 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Jun 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.
The study seeks to compare the single-incision lateral mammoplasty technique with the matrix rotation flap in patients with breast carcinoma. The primary outcome assessed is postoperative complications, while secondary outcomes include cosmetic appearance and patient satisfaction.
Detailed description
This study is designed to conduct a comprehensive comparison between two breast-conserving surgical techniques used in the treatment of breast carcinoma: the single-incision lateral mammoplasty and the matrix rotation flap. These procedures are employed to achieve both oncologic safety and aesthetic preservation in patients undergoing surgery for breast cancer.
The primary objective of the study is to evaluate and compare the incidence and nature of postoperative complications associated with each technique. This includes, but is not limited to, wound healing issues, infection rates, hematoma or seroma formation, and any need for reoperation.
Secondary objectives focus on assessing the cosmetic outcomes and the overall satisfaction of the patients post-surgery. Cosmetic evaluation will be conducted through both surgeon-assessed and patient-reported outcomes, utilizing standardized scoring systems and photographic documentation. Patient satisfaction will be measured through validated questionnaires designed to capture perceptions of body image, aesthetic results, and quality of life following the procedure.
By systematically analyzing these parameters, the study aims to determine which technique offers a more favorable balance of surgical safety, aesthetic quality, and patient satisfaction, thereby guiding clinical decision-making in breast-conserving surgery for breast carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group MRF | Experimental | Other: Technique surgeryMatrix rotation flap MRF surgical procedure |
| Group SLIM | Experimental | Other: proceduder surgerySingle Incision Lateral Sulcus Mammoplasty (SLIM). |
Who may qualify
- Ages
- 42 to 61 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Upper Quadrant Breast Carcinomas.
Key exclusion criteria (1 listed)
- Patients with T4 tumors, inflammatory breast cancer and distant metastasis, multi-centric breast cancer in more than one quadrant and diffuse microcalcifications were excluded from the study.
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 |
|---|---|---|
| proceduder surgeryThe single-incision lateral sulcus mammoplasty is a breast-conserving surgical technique that involves making a single incision along the lateral aspect of the inframammary fold or within the natural skin crease of the lateral sulcus. This approach provides direct access to the lateral quadrants of the breast, which are commonly affected in breast carcinoma, allowing for effective tumor excision while preserving the breast contour. In SILSM, the incision is carefully planned to align with natural anatomical lines, ensuring optimal cosmetic results and minimal visible scarring. Through this lateral access point, the surgeon performs both tumor resection and glandular reshaping. The technique often involves mobilization and rearrangement of the remaining breast tissue to fill the defect left by the tumor excision, thereby maintaining breast symmetry and volume. This techn | Other | Group SLIM |
| Technique surgeryThe matrix rotation flap is a versatile oncoplastic surgical technique employed in the reconstruction of partial breast defects following tumor excision. This method involves the creation of a rotational skin and glandular flap, mobilized from adjacent breast tissue, typically using an inferolateral or inferomedial pedicle. The flap is designed in a curvilinear or semicircular fashion, allowing it to rotate into the defect site while maintaining adequate vascular supply. The MRF technique is particularly useful for defects in the lower quadrants of the breast, where direct tissue advancement may be limited. The surgeon carefully outlines a skin paddle adjacent to the resection cavity and undermines the surrounding breast parenchyma. The flap is then rotated and inset into the tumor bed to fill the defect, with the skin paddle contributing to both volume replacement and skin resurfacing if required. This approach provides robust coverage of the surgical cavity, helps restore breast co | Other | Group MRF |
Primary outcome
Postoperative complications
Time frame: 4 weeks
The total number (percentage) of participants in each group who got post-operative complications such as wound infection, hematoma, and seroma.
2 secondary outcomes
Asthetic outcomes
Time frame: 6 months
Patients' satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 30620402Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.
- pubmed official siteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Will be available upon approval of the funding institute
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proceduder surgery and Technique surgery in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Batterjee Medical College 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 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: finished, as of the sponsor's last update on 15 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07022509, which also lists 1 linked publication.
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 15 Jun 2025.