Matrix Rotation Flap Versus Single Incision Lateral Sulcus Mammoplasty

NCT ID: NCT07022509

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-07
• Study Completion Date: 2024-06-01

Brief 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.

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.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group MRF

Matrix rotation flap MRF surgical procedure

Group Type: EXPERIMENTAL

Technique surgery

Intervention Type: OTHER

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

Group SLIM

Single Incision Lateral Sulcus Mammoplasty (SLIM).

Group Type: EXPERIMENTAL

proceduder surgery

Intervention Type: OTHER

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

Interventions

proceduder surgery

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

Intervention Type: OTHER

Technique surgery

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 42 Years
• Maximum Eligible Age: 61 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Batterjee Medical College

OTHER

Sponsor Role: lead

Responsible Party

Osama Ragaa Abdelraouf Ibrahim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Benha University, Benha, Egypt

Giza, Cairo Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 30620402 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/30620402/

pubmed official site

Other Identifiers

PNURSP2025R168

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC 9-4-2022

Identifier Type: -

Identifier Source: org_study_id