This is an RCT to compare postoperative outcomes between Robotic and conventional nipple-sparing mastectomy with immediate breast reconstruction in Indian breast cancer patients

Assessing Postoperative outcomes between Robotic and Conventional Nipple-Sparing Mastectomy with Immediate Breast Reconstruction - A Phase II Randomized Controlled Trial - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113974

Enrollment

Registered

2026-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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: Robotic nipple sparing mastectomy: All the patients randomised under robotic arm will be undergoing nipple sparing mastectomy procedure by robotic approach during surgery and will be pe

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 years or older. 2. Diagnosed with Breast cancer cT1-cT3 and those undergoing Nipple Sparing Mastectomy with Immediate breast reconstruction - either as upfront or post NACT setting. 3. Risk reducing Mastectomy in BRCA+ patients 4. Presumptive adequate skin flap thickness more than 8mm on mammogram. 5. Patient should be well oriented and coherent. 6. Both unilateral and bilateral breast surgery cases will be included.

Exclusion criteria

Exclusion criteria: 1. Locally advanced T4 tumours. 2. Metastatic Breast cancer 3. Patients with intraoperatively inadequate skin flaps 4. Prior radiotherapy to the chest wall 5. Not consenting for the trial

Design outcomes

Primary

Measure	Time frame
To assess the postoperative outcomes between Robotic and Conventional Nipple sparing mastectomy with immediate breast reconstruction in terms of skin flap and NAC survival and preservation of skin sensationTimepoint: 10,30,60 and 90 days post surgery	—

Secondary

Measure	Time frame
Need for postoperative analgesiaTimepoint: First 10 days post surgery;Drain use durationTimepoint: 5 to 15 days post surgery;Quality of lifeTimepoint: 10,30,60 and 90 days post surgery	—

Countries

India

Contacts

Public ContactBalaji P K

AIIMS New Delhi

drashutoshmishra11@gmail.com9650638722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026