Actively Recruiting
Surgical Intervention for Refractory Granulomatous Lobular Mastitis
Led by Wuhan University · Updated on 2020-11-20
300
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgical Intervention for Refractory Granulomatous Lobular Mastitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with abscess, sinus fistula, skin rupture, or other complex lesions
- Patients who voluntarily agree to participate after informed consent
You will not qualify if you...
- Patients diagnosed with mastitis from other confirmed causes by pathology
- Patients choosing conservative treatment without surgery
- Patients with other serious diseases unable to tolerate surgery
- Pregnant patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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