跳至主要内容
临床试验/NCT04637711
NCT04637711招募中不适用

Randomized Controlled Trial for 'Focus Clearing + Whole Breast Exploration and Washing + One-Stage Micro Plastic Surgery' Treatment for Granulomatous Lobular Mastitis

Wuhan University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020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
300
试验地点
1
主要终点
Recurrence rate

研究概览

简要总结

Granulomatous lobular mastitis (GLM) belongs to a group of benign diseases, which is mainly treated with glucocorticoids and surgical treatment. Nowadays, in China, surgical treatment has gradually become the mainstream, but the timing and the extent of surgery are still controversial, and different literatures report that the recurrence rate after surgery is 20-50%. Empirical lesion resection is generally used. We believe that the main reason for the high recurrence rate is the incomplete removal of the breast lesions. Because GLM is often characterized with microabscesses formation, empirical resection is likely to have residual lesions that are not visible to the naked eye. In order to reduce the postoperative recurrence rate and protect the breast appearance as much as possible, we propose a surgical plan : granulomatous lobular mastitis "lesion removal + whole breast exploration and flushing + one-stage microplastic surgery". The purpose of this study was to compare this surgical scheme of granulomatous lobular mastitis with existing surgical schemes, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients, and standardize GLM surgical schemes.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 18 years or older with granulomatous lobular mastitis
  • Patients without surgical treatment;
  • Extensive lesions involving two or more quadrants of the breast, or accompanied by abscess, sinus fistula formation, skin rupture and other complex lesions;
  • Patients volunteered to participate in the study after informed consent.

排除标准

  • Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
  • Patients who chose conservative treatment and did not receive surgical treatment
  • Combined with other basic diseases, unable to tolerate surgery
  • Patients in pregnancy.

结局指标

主要结局

Recurrence rate

时间窗: Up to 2 years

Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast within one year after surgery was defined as recurrence.

次要结局

  • Breast appearance and cosmetic effect score(Up to 2 years)
  • Surgical incision healing time(Up to 2 months)

研究者

发起方
Wuhan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gaosong Wu, Ph D, MD

Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University

Wuhan University

研究点 (1)

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