Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis

Study Overview
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Brief Summary
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This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.

Detailed Description
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Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer. Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference. Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.

Official Title
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Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis

Conditions
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Granulomatous Mastitis

Intervention / Treatment
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* Drug: Hydrocortisone Butyrate
* Procedure: extended excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Granulomatous Mastitis Exclusion Criteria: Breast Carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical<br>Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment. | Drug: Hydrocortisone Butyrate<br>* topical use<br>|
| Active Comparator: surgical<br>lesion extended excision | Procedure: extended excision<br>* Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response rate | The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| granulomatous mastitis recurrence |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Granulomatous, Mastitis, topical steroids