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临床试验/NCT06712524
NCT06712524招募中不适用

A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome of Granulomatous Mastitis

Hubei Cancer Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
1
主要终点
Recurrence rate

研究概览

简要总结

The objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. The patients were divided into traditional surgery group and plastic surgery group.

详细描述

Granulomatous mastitis is a rare benign inflammatory breast disease first described by Kessler and Wollock in 1972. It resembles inflammatory breast cancer disease in imaging and mainly affects women of childbearing age. Treatment methods include steroid therapy, antibiotics and surgical treatment. However, due to the adverse reactions of drug treatment and the high recurrence rate after traditional surgery, there is no definitive preferred treatment form at present, and most clinicians are still in the stage of empirical treatment.

Breast-conserving plastic surgery has been widely used by surgeons because it can remove a larger range of breast cancer, so it has higher safety and aesthetics compared with traditional breast conserving surgery. So, if patients with mastitis are treated surgically, will they also benefit from breast-conserving surgery? At present, the commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on. Therefore, this study prospectively grouped mastitis patients who selected surgery, and divided them into traditional surgery group and plastic breast-conserving surgery group. The postoperative recurrence, adverse reactions, aesthetics and satisfaction of the two groups were compared.

It is hoped that this study will bring a new research direction for the surgical treatment of mastitis and provide a clearer guiding significance for clinical decision-making.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Only the subjects who meet all the following criteria may be included in this study:
  • Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
  • 18≤Age≤75 years old, female;
  • Histologically confirmed granulomatous mastitis;
  • low and moderate risk for anesthesia.

排除标准

  • The subjects who meet any of the following criteria shall not be included in this study:
  • Absolute and relative contraindication for surgery;
  • Previous history of breast cancer or other malignancies;
  • Any serious complications which caused patients not suitable to participate this study.

结局指标

主要结局

Recurrence rate

时间窗: 2, 3, 5 year

The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.

次要结局

  • Aesthetics scores(2, 3, 5 year)

研究者

发起方
Hubei Cancer Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongmei Zheng, PhD

Doctor

Hubei Cancer Hospital

研究点 (1)

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