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临床试验/NCT07022509
NCT07022509已完成不适用

Outcome Of Matrix Rotation Versus Single Incision Lateral Sulcus Mammoplasty In The Upper Quadrant Breast Carcinomas

Batterjee Medical College1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Postoperative complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Statisticians

入排标准

年龄范围
42 Years 至 61 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Upper Quadrant Breast Carcinomas.

排除标准

  • •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.

研究组 & 干预措施

Group MRF

Experimental

Matrix rotation flap MRF surgical procedure

干预措施: Technique surgery (Other)

Group SLIM

Experimental

Single Incision Lateral Sulcus Mammoplasty (SLIM).

干预措施: proceduder surgery (Other)

结局指标

主要结局

Postoperative complications

时间窗: 4 weeks

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

次要结局

  • Asthetic outcomes(6 months)
  • Patients' satisfaction(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Ragaa Abdelraouf Ibrahim

Professor

Batterjee Medical College

研究点 (1)

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