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management of blood related nipple discharge by removal of milk ducts

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033613
Enrollment
60
Registered
2021-05-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D367- Benign neoplasm of other specifiedsites Health Condition 2: D249- Benign neoplasm of unspecified breast Health Condition 3: O- Medical and Surgical

Interventions

Intervention1: MAMMARY DUCT EXCISION - 2.5 cm: In patients presenting with serosanguinous nipple discharge, evaluation will be done using USG/mammogram to rule out malignancy. After which mammary duct

Sponsors

Department of Surgical Disciplines
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 dischargeTimepoint: 3 and 6 months—

Secondary

MeasureTime frame
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. 3. Comparison of recurrence rate in both arms Timepoint: 3 and 6 months—

Countries

India

Contacts

Public ContactDr Suneha Kumari

All India Institute of Medical Sciences

dranitadharbhan@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026