Comparison Of Patient Reported Outcomes In Patients With Blood Related nipple discharge undergoing mammary Duct Excision With 2.5 Cm Versus 5 Cm Length : A Randomised Controlled Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare complication rate (nipple necrosis, nipple anaesthesia, retraction, scarring) in patients undergoing duct excision (Major duct excision/ microdochectomy) with 5 cm margin versus 2.5 cm margin in patients with blood related nipple discharge
研究概览
简要总结
Benign breast diseases are a heterogenous group of disorder affecting women. One of the entity of this group is intraductal papilloma (IDP) which can present as nipple discharge or rarely remain asymptomatic. IDP are associated with a small increase in risk of malignancy. The treatment of IDP is by surgical excision either by major duct excision or microdochectomy, depending on age of the lady and completion of family size. Traditional teaching advocated excision with 5 cm length of ducts being excised. Extensive dissection beneath the nipple can lead to nipple necrosis, nipple anaesthesia and nipple retraction. Since many papilloma are located within 2 cm of duct from the nipple, few surgeons now recommend removal of ducts with 2.5 cm extent, which can reduce the amount of dissection and hence the associated complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •a) Ladies presenting with blood-related nipple discharge b) No family history/ past history of carcinoma breast/ Ductal carcinoma in-situ.
排除标准
- •a)clinically/ sonographically detected discrete breast lump b)patient not willing for surgery c)pregnant ladies/ lactating ladies d)pre-surgery biopsy suggestive of atypia/ DCIS e)past history of carcinoma breast f)patients harboring mutations predisposing to breast cancer g)family history of breast cancer.
结局指标
主要结局
To compare complication rate (nipple necrosis, nipple anaesthesia, retraction, scarring) in patients undergoing duct excision (Major duct excision/ microdochectomy) with 5 cm margin versus 2.5 cm margin in patients with blood related nipple discharge
时间窗: 3 and 6 months
次要结局
- 1. To compare the cosmetic outcomes in both arms.(2. To assess patient satisfaction rate in terms of pre and post-operative pain and resolution of symptoms in both arms.)