NCT07022509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

May 30, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

breast cancerOncologyMRFSLIM

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    The total number (percentage) of participants in each group who got post-operative complications such as wound infection, hematoma, and seroma.

    4 weeks

Secondary Outcomes (2)

  • Asthetic outcomes

    6 months

  • Patients' satisfaction

    6 months

Study Arms (2)

Group MRF

EXPERIMENTAL

Matrix rotation flap MRF surgical procedure

Other: Technique surgery

Group SLIM

EXPERIMENTAL

Single Incision Lateral Sulcus Mammoplasty (SLIM).

Other: proceduder surgery

Interventions

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

Group SLIM

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 MRF

Eligibility Criteria

Age42 Years - 61 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Upper Quadrant Breast Carcinomas.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Benha University, Benha, Egypt

Giza, Cairo Governorate, 13511, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 30620402BACKGROUND

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Statisticians
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 15, 2025

Study Start

May 7, 2022

Primary Completion

December 17, 2023

Study Completion

June 1, 2024

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Will be available upon approval of the funding institute

Locations