Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
NCT04637711

Surgical Intervention for Refractory Granulomatous Lobular Mastitis

Led by Wuhan University · Updated on 2020-11-20

300

Participants Needed

1

Research Sites

347 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Surgical Intervention for Refractory Granulomatous Lobular Mastitis

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 with abscess, sinus fistula, skin rupture, or other complex lesions
  • Patients who voluntarily agree to participate after informed consent
Not Eligible

You will not qualify if you...

  • Patients diagnosed with mastitis from other confirmed causes by pathology
  • Patients choosing conservative treatment without surgery
  • Patients with other serious diseases unable to tolerate surgery
  • Pregnant patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430071

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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