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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Time Frame
Start Date: 2020-11-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 300
Treatments
Experimental: Specific surgical Intervention
Focus clearing + whole breast exploration and washing + one-stage micro plastic surgery
No_intervention: Extensive lesion excision
Related Therapeutic Areas
Sponsors
Leads: Wuhan University

This content was sourced from clinicaltrials.gov