NCT04637711

Surgical Intervention for Refractory Granulomatous Lobular Mastitis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Wuhan University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

• Refractory Granulomatous Lobular Mastitis

Interventions

Type	Name	Description
PROCEDURE	Focus clearing + whole breast exploration and washing + one-stage micro plastic surgery No Intervention: Extensive lesion excision	Only visible lesions and necrotic tissues, such as abscess cavity, sinus tract and fistula, were removed intraoperatively, while normal glands and fat were retained. Preoperative ultrasound was used to locate the lesion area and then the surgical incision was designed. Intraoperative ultrasound examination of latent small lesions, resection of lesions visible under ultrasound, and then a full breast exploration, one finger page incision interval.Radially cut from the base to the subcutaneous, lesions were found and treated locally. After removal of lesion, fully using the syringe, in turn, use of 3% hydrogen peroxide solution, 1% eniodine, saline water is widely jet pulse washing, and around the lesions base. After rinsing, soak in 1% active iodine for 10min, then rinse with normal saline until the liquid is clear. Breast tumor Surgery (Oncoplastic Breast Surgery, OBS) core technology (volume replacement and volume replacement).

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-06-30
• Completion: 2027-06-30
• First posted: 2020-11-20
• Last updated: 2020-11-20

Locations

1 site across 1 country: China