Matrix Rotation Flap Versus Single Incision Lateral Sulcus Mammoplasty

Not Applicable

Completed

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

• Registration Number: NCT07022509
• Lead Sponsor: Batterjee Medical College

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.

Study Timeline

• Study Start: 2022-05-07
• Primary Completion: 2023-12-17
• Study Completion: 2024-06-01
• Study First Submitted: 2025-05-30
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative complications	4 weeks	The total number (percentage) of participants in each group who got post-operative complications such as wound infection, hematoma, and seroma.

Secondary Outcome Measures

Name	Time	Method
Asthetic outcomes	6 months	Vancouver's scar scale with ranges from 0 (normal skin) to 13 (worst scar possible)
Patients' satisfaction	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.

Trial Locations

Locations (1)

Faculty of Medicine, Benha University, Benha, Egypt; 🇪🇬 Giza, Cairo, Egypt