Granulomatous, Mastitis Clinical Trial
Official title:
Granulomatous Mastitis Current Approach and Treatment (Multicentric Study) Granulomatous Mastitis Working Group
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.
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.
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