The Effect of the Combination of Excision and Intraoperative Steroid Administration in Idiopathic Granulomatous Mastitis
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The effect of excision and intraoperative steroid administration to the cavity in Idiopathic Granulomatous Mastitis.
研究概览
简要总结
After breast cancer, diopathic Granulomatous Mastitis (IGM) is among the breast diseases that bother patients and clinicians the most. Countries with a coast to the Mediterranean, especially our country, are the most common geography of this disease. For this reason, a significant part of the important scientific publications about IGM in the last 3-4 decades are from the countries of this geography and mainly from our country. The paradigm of whether IGM should be treated medically or surgically is still a matter of debate. Today, effective treatment results can be achieved with medical treatments, and local drug applications are finding an increasing application area in order to reduce the systemic drug level due to the side effects often seen in this process. As in the centers dealing with breast diseases intensively in our country, patients are treated in our center both by systemic and local means.
Within the body of the Turkish Breast Diseases Federation, after the plans made with the employees of the leading breast centers of the International Breast Health Working Group International planned to start a recording study to observe the activity between, local treatment in the lesion without surgical treatment with systemic treatment in IGM treatment and local treatment together with surgical treatment.
详细描述
AIM:
Primary: The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on the shortening of the recovery period in Idiopathic Granulomatous Mastitis.
Secondary: Comparison of the side effects and the relationship between the treatment method and the serum cortisol level in patients treated with intralesional steroid + low dose oral steroid and topical steroid
THE WORK PLAN:
A prospective registry study was designed to compare the effectiveness of the combination of intralesional steroid administration used in the treatment of IGM + low-dose oral steroid therapy used together with the combination of surgical excision and intraoperative intra-cavity steroid administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with IGM histopathologically
- •Patients in groups A, B and C according to clinical classification
- •Ultrasonographically; Patients with leaf-like hypoechoic type, localized abscess type, and localized hypoechoic mass type mastitis
排除标准
- •Patients diagnosed with tumor after biopsy
- •Those with TB PCR (+)
- •Presence of clinically widespread abscess and cellulite (group D patients)
- •Ultrasonographically; diffuse diffuse type
- •Pregnancy
- •Breastfeeding period
研究组 & 干预措施
NON-SURGERY GROUP
Group 1: Patients whose serum cortisol level was observed before starting the treatment, who were injected with 40 mg of prednol at 4 weeks intervals for 3 months for each lesion. The total monthly dose will not exceed 120 mg, and the total 3-month dose will not exceed 200 mg. In this group of patients, the serum cortisol level should have reappeared on the 2nd or 3rd day following each intralesional administration. In this group of patients, low-dose oral prednol (<30 mg/day) and/or topical prednol cream can be applied twice a day during the treatment.
干预措施: Intralesional steroid administration (Procedure)
SURGERY GROUP
In patients included in Group 2, serum cortisol levels should have been observed before starting treatment. Then the patients should be operated and the mass(s) should be excised. Intraoperatively, not less than 40 mg of prednol should be injected into each mass cavity (it may vary according to the cavity diameter), and the amount applied to all cavities should not exceed 200 mg in total. The amount of prednol administered for each cavity should be recorded. In this group of patients, prednol may have been administered to the cavity walls (Group 2a) or inside the cavity (Group 2b). Serum cortisol levels should be seen in patients 7 to 10 days after the procedure.
Group 2a: 4 Quadrants 40 mg predmol per cavity wall (for < 2cm lesion and an additional 20 mg for each additional 1 cm) Group 2b: 40 mg predmol into the cavity (for < 2 cm lesion and an additional 20 mg for each additional 1 cm)
干预措施: Intraoperative cavity steroid administration (Procedure)
结局指标
主要结局
The effect of excision and intraoperative steroid administration to the cavity in Idiopathic Granulomatous Mastitis.
时间窗: one year
The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on outcome in Idiopathic Granulomatous Mastitis.
次要结局
- Correlation of treatment modality and serum cortisol levels.(one year)
- Rate of side effects in patients who received intralesional steroid(one year)
研究者
Huseyin Ozgur Aytac
Assoc Prof
Baskent University