Granulomatous Mastitis Current Approach and Treatment
Condition: Granulomatous, Mastitis
MeSH terms: Mastitis; Granulomatous Mastitis
Study type: Observational

Summary: 
      The aim of this study was to retrospectively review the granulomatous mastitis and evaluated
      current approach and treatment.

      HYPOTHESIS Although there is no common protocol for the treatment and management process of
      GM, the ternary treatment (medical treatment following by surgical procedure,
      Steroid+Antibiotic and surgical procedure, respectively) is considered as the most successful
      treatment approach.
    

Detailed description: 
      INTRODUCTION Granulomatous mastitis (GM) is a rare inflammatory disease of the breast which
      generally affects young parous women. It was emphasized that lactation and using oral
      contraceptive are considered among the predisposing factors of the disease. GM is firstly
      identified in 1972, and it is considered as an important disease because it is a great
      mimicker of breast carcinoma.

      The form of treatments involves corticosteroids, antibiotics and general surgical resections
      including mastectomy. Furthermore, a preferred form of treatment has not been defined yet.
      Also, there are not enough data showing the results of using antibiotics. Since GM is a rare
      disease, there is no common consensus for the diagnosis and treatment of GM. The
      uncertainties about the distinct diagnosis, determining the form and term of treatment, the
      order of treatment if necessary, as well as what medical specialties need to involve in the
      treatment process still remain. Therefore, all these uncertainties cause a difficulty to
      manage the treatment process by physicians. Furthermore, since there is no enough study on GM
      and only limited case reports was presented in the literature, the success of treatment
      process is associated with the experience of treatment center. Therefore, there is a clear
      need for multicentric study that compares different approaches of the treatment process with
      the enough number of cases.

      DATA COLLECTION In this study, patient's data will be retrospectively obtained by recording
      the data in patients' files and electronic records. The data includes the determined
      parameters by the study group of GM and the data will be recorded in an excel file that
      includes specific columns of the following entries: patients' age, diagnosis, secondary
      disease, diagnosis methods, treatments, recurrence, the risk factors that may cause the
      disease (smoking, using oral contraceptive, breast infection etc.). A shared excel file at
      the following website http://sanko.edu.tr/GranulamatozMastit has been created to record the
      data simultaneously. Each researcher can add the data at the file by using username and
      password. After data collection, the data will be presented mean+StDv. Statistical analysis
      will include Mann-Whitney U test, student's t test and chi-square test and statistical
      significance will set at P< 0.05. The treatment group in this study will be divided as
      medical, surgical and medical+surgical and the comparison among these groups will be
      conducted to reach the aims determined in expected outcomes section. The sample size and
      power analysis were conducted and the results indicated that at least 100 samples in each
      group are required to achieve the statistical significance at P< 0.05 with 90% power. The
      estimated total cases are expected over 400 cases.

      EXPECTED OUTCOMES

        1. Potential etiologies will be investigated.

        2. The results will shed light on the optimal management method for patients with GM.

        3. The treatment duration and order will be revealed.

        4. Treatment and management algorithm will be created.

        5. The hypothesis on the success of ternary treatment approach will be tested.

        6. Creation of a prognostic index for GM will be tried.

        7. Since a multicentric study is planned, experiences and results from different centers
           will be investigated.

        8. Since the study will be multicentric with enough number of cases, the true statistical
           results will be obtained.

        9. Among which medical specialties should be involved in communication during the
           determination of diagnosis and treatment will be revealed.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        from 18 to 90 years womens with Granulomatous Mastitis
      
Keywords: Granulomatous, Mastitis; C17.800.090.968.400; C13.703.844.603.400