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临床试验/CTRI/2015/01/005440
CTRI/2015/01/005440招募中不适用

INVESTIGATION OF CLINICAL TYPES, HORMONAL PROFILE AND TREATMENT OUTCOMES IN PATIENTS WITH GYNECOMASTIA

AIIMS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
AIIMS
入组人数
30
试验地点
1
主要终点
Cosmesis score

研究概览

简要总结

Gynecomastia is a common condition such that nearly 40% all boys develop this condition during puberty and 36% of men aged 17-58 years have palpable breast tissue. Nearly two-thirds of patients have been reported in western literature to respond to tamoxifen therapy. In the rest, surgical management in pursued in the form of subcutaneuos mastectomy with good surgical results. There have been multiple case reports on gynecomastia from Indian sub-continent but not a single large series has yet been published. Here at AIIMS outpatient department, we come across a large number of patients with gynecomastia and operate on thirty to forty cases each year. Thus a dedicated reserch with an aim to document the clinical types, hormonal profile and treatment outcomes of gynecomastia will add up significantly to the existing literature.

 In our study, patients with gynecomastia will be recruited from surgical or endocrinology OPD. Patients will be evaluated with clinical examination and pertinent investigations including ultrasound and biopsy. Patients will be prescribed 20 mg/day of tamoxifen for three to six months unless they have any contraindication to tamoxifen. Patients will be reassessed after three months of tamoxifen therapy to check the response. If there is significant reduction in breast volume (> 50% reduction) at three months, then tamoxifen will be continued for further 3 months. Patients with minimal or no response will be randomized to undergo either a one stage or 50-50 two stage subcutaneous mastectomy (half of the breast plate excised by circumareolar incision and repeat excision of remaining half 3 months later). Patients will be followed up in clinic for final surgical outcome assessment at 6 months.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • •Patients coming to surgical/ endocrinology OPD with the diagnosis of gynecomastia.

排除标准

  • •Patients who are unwilling or unable to provide informed consent.
  • •Patients who have contraindications to tamoxifen therapy viz history of thromboembolism, stroke, and coronary artery disease.

结局指标

主要结局

Cosmesis score

时间窗: 6 months from surgery

次要结局

  • Surgical complications(Withing 6 months of surgery)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital

研究点 (1)

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