[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559570":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":47,"overallOfficials":58,"centralContacts":62,"locations":68,"responsibleParty":85,"collaborators":26,"id":87,"slug":26,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":26,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":26,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"First Affiliated Hospital of Harbin Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":26},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Differences in the cure rate of the three treatment modalities","According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The cure rate was compared among the three groups.","Baseline",{"measure":14,"description":15,"timeFrame":12},"Differences in the recurrence rate of the three treatment modalities","According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The recurrence rate was compared among the three groups.",{"measure":17,"description":18,"timeFrame":12},"Differences in the incidence of adverse reactions of the three treatment modalities","According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The incidence of adverse reactions was compared among the three groups.",[20,23],{"measure":21,"description":22,"timeFrame":12},"Differences in the patient satisfaction score (points) of the three treatment modalities","According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The patient satisfaction score (points) was compared among the three groups.",{"measure":24,"description":25,"timeFrame":12},"Differences in the treatment duration (months) of the three treatment modalities","According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The treatment duration (months) was compared among the three groups.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"CASE_CONTROL","RETROSPECTIVE","In recent years, the incidence of this disease has been increasing annually. The incidence of GLM is region-specific, being higher in Mediterranean regions and Asian countries. The etiology is currently unclear, but many studies suggest that GLM is associated with autoimmune disorders, hormonal imbalances, and microbial infections . GLM has a long course, is difficult to treat, and prone to recurrence, causing significant trauma to the patient's breast appearance and overall well-being. Currently, the main treatment methods for GLM include surgical treatment, drug therapy, combined surgery with drug therapy, and close observation. Surgical treatment options mainly include abscess incision and drainage, segmental resection, subcutaneous mastectomy, mastectomy, and breast reconstruction. Although surgical treatment can rapidly improve the condition, the recurrence rate reported in the literature ranges from 5% to 50% . Although GLM is a benign disease, it can severely impact the patient's normal life, causing physical and psychological trauma. However, few studies have included patients' subjective treatment experiences in the evaluation of treatment outcomes.\n\nTo date, there have been no studies comparing the efficacy of three treatment methods (surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy) in the same population of GLM patients. This study aims to compare the efficacy and patient satisfaction of these three treatment methods, with the hope of providing new insights for clinical treatment options.","Female patients with GLM who were treated at the Breast Surgery Department of the First Affiliated Hospital of Harbin Medical University were selected.Patients with GLM mostly present with unilateral disease, and the lesions can be located in any part of the breast. Arthritis and lower limb erythema nodosum are rare.",[33,38,43],{"label":34,"type":26,"description":35,"interventionNames":36},"surgery group","The patients underwent surgery",[37],"Procedure: Surgery",{"label":39,"type":26,"description":40,"interventionNames":41},"triple anti-tuberculosis drug therapy group","The patients were treated with triple anti-tuberculosis drugs",[42],"Drug: triple anti-tuberculosis drug",{"label":44,"type":26,"description":45,"interventionNames":46},"combination therapy group","The patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery",[37,42],[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":26},"PROCEDURE","Surgery","patients underwent complete excision of the inflammatory breast tissue and some surrounding normal tissue under combined intravenous with inhalation anesthesia. Damaged skin was also removed.",[44,34],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":26},"DRUG","triple anti-tuberculosis drug","Patients took oral rifampin (450 mg\u002Fday), isoniazid (300 mg\u002Fday), and ethambutol (15 mg\u002Fkg\u002Fday).",[44,39],[59],{"name":60,"affiliation":5,"role":61},"Jing Feng","STUDY_DIRECTOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":26,"email":67},"Yi Zhou","CONTACT","+86-0451-85552102","lubj2001@163.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"First affiliated hospital of Harbin medical university","RECRUITING","Harbin","Heilongjiang","150001","China","CN",{"type":78,"coordinates":79},"Point",[80,81],126.65,45.75,{"lat":81,"lon":80},[84],{"name":64,"role":65,"phone":66,"phoneExt":26,"email":67},{"type":86,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100559570",false,"NCT06565845","Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis","Analysis of the Clinical Characteristics and Three Treatment Methods of Granulomatous Lobular Mastitis","Inclusion Criteria:\n\n* non-lactating and aged 15-65 years\n* histopathological confirmation of GLM\n* normal liver and kidney function\n\nExclusion Criteria:\n\n* lactating and pregnant women\n* allergies to rifampin, isoniazid, or ethambutol\n* concurrent malignant breast tumors\n* severe underlying diseases\n* other conditions deemed unsuitable by the investigator and\n* refusal to participate in the study","FEMALE","15 Years","65 Years",{"count":97,"type":98},350,"ESTIMATED","OBSERVATIONAL","Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.",[102],"Granulomatous Mastitis",[104,105,106,107],"Granulomatous lobular mastitis","surgical treatment","antituberculosis therapy","surgery combined with anti-tuberculosis therapy","2024-08-21",{"date":110,"type":111},"2024-08-22","ACTUAL",{"date":113,"type":111},"2024-08-19",{"date":115,"type":98},"2024-10-19",{"name":5,"class":6},1]