management of blood related nipple discharge by removal of milk ducts

Not yet recruiting

Conditions: Benign neoplasm of unspecified breast, (2) ICD-10 Condition: D367||Benign neoplasm of other specifiedsites, (3) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2021/05/033613

Lead Sponsor: Department of Surgical Disciplines

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 60

Inclusion Criteria

a) Ladies presenting with blood-related nipple discharge b) No family history/ past history of carcinoma breast/ Ductal carcinoma in-situ.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): AIIMS New Delhi
🇮🇳
South, DELHI, India
AIIMS New Delhi
🇮🇳South, DELHI, India
Dr Anita Dhar
Principal investigator
9810198239
dranitadharbhan@gmail.com