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Surgical Intervention for Refractory Granulomatous Lobular Mastitis

NCT04637711 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-11-20

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Wuhan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04637711 on ClinicalTrials.gov