Surgical Intervention for Refractory Granulomatous Lobular Mastitis

Not Applicable

Recruiting

• Conditions: Refractory Granulomatous Lobular Mastitis

• Registration Number: NCT04637711
• Lead Sponsor: Wuhan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-01
• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Study First Posted: 2020-11-20
• Last Update Posted: 2020-11-20
• Primary Completion: 2022-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence rate	Up to 2 years	Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast within one year after surgery was defined as recurrence.

Secondary Outcome Measures

Name	Time	Method
Breast appearance and cosmetic effect score	Up to 2 years	Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.
Surgical incision healing time	Up to 2 months	Surgical incision healing time was defined as the time from the first day after the operation to the healing time of the surgical incision. The wound surface was dry, there was no effusion, and no surgical incision complications occurred

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China