Matrix Rotation Flap Versus Single Incision Lateral Sulcus Mammoplasty (SLIM)

June 13, 2025 updated by: Osama Ragaa Abdelraouf Ibrahim, Batterjee Medical College

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cairo
      • Giza, Cairo, Egypt, 13511
        • Faculty of Medicine, Benha University, Benha, Egypt

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Upper Quadrant Breast Carcinomas.

Exclusion Criteria:

  • 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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group MRF
Matrix rotation flap MRF surgical procedure

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

Experimental: Group SLIM
Single Incision Lateral Sulcus Mammoplasty (SLIM).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthetic outcomes
Time Frame: 6 months
Vancouver's scar scale with ranges from 0 (normal skin) to 13 (worst scar possible)
6 months
Patients' satisfaction
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

May 7, 2022

Primary Completion (Actual)

December 17, 2023

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

May 30, 2025

First Submitted That Met QC Criteria

June 13, 2025

First Posted (Actual)

June 15, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • RC 9-4-2022
  • PNURSP2025R168 (Other Grant/Funding Number: Princess Nourah bint Abdulrahman University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will be available upon approval of the funding institute

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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