Surgical Intervention for Refractory Granulomatous Lobular Mastitis
Recruiting now · Not applicable
Conditions studied: Refractory Granulomatous Lobular Mastitis
In brief
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.
Key facts
- Study ID
- NCT04637711
- Run by
- Wuhan University
- People needed
- 300
- Starts
- 2020-11-01
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2020-11-20
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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