Surgical Intervention for Refractory Granulomatous Lobular Mastitis

Wuhan University

Status

Enrolling

Conditions

Refractory Granulomatous Lobular Mastitis

Treatments

Procedure: Focus clearing + whole breast exploration and washing + one-stage micro plastic surgery No Intervention: Extensive lesion excision

Study type

Interventional

Funder types

Other

Identifiers

NCT04637711

KYL[2020091]

Details and patient eligibility

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.