surgery for non-bloody nipple discharge

Nipple discharge in women; Evaluation and Randomized trial comparing limited length ductal cone excision (1.5 cm) with 3 cm ductal cone excision in women presenting with non-bloody nipple discharge.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020442

Enrollment

380

Registered

2019-07-30

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: O- Medical and Surgical

Interventions

Intervention1: radical duct excision 1.5 cm ductal cone excision: non bloody nipple discharge 1.5 cm ductal cone excision Control Intervention1: radical duct excision 3 cm ductal cone excision: non-bl

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ladies with spontaneous, non-bloody nipple discharge from multiple ducts due to Periductal mastitis/ Duct ectasia 2. Willingness to sign the informed written consent

Exclusion criteria

Exclusion criteria: 1. Palpable lump in the breast 2. Suspicious lesion in breast imaging 3. Atypical or malignant cells reported in the cytopathological examination of nipple discharge smear

Design outcomes

Primary

Measure	Time frame
Measures recurrence of nipple discharge at 3 months coded as Yes/NoTimepoint: 3 months	—

Secondary

Measure	Time frame
1. Measures Wound related complications such as haematoma, surgical site infection, nipple-areola necrosis and pain coded as Yes/No at 1, 2 and 4 weeks. 2. Nipple-areola sensation at 3 months recorded as normal/reduced/absent. 3. Cosmesis at 3 months recorded as ordinal scale, excellent/good/fair/poor. Timepoint: 3 months	—

Countries

India

Contacts

Public Contactirfan v

All India Institute of Medical Sciences

dranitadharbhan@gmail.com9810198239

Outcome results

None listed

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