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The effect of 1 cm versus 2 cm resection margin and oncoplastic closure of breast parenchymal defect on immediate postoperative complications, cosmesis and patient satisfaction in women with early breast cancer (upto 4 cm): A 2 X 2 factorial design randomized controlled trial

The effect of 1 cm versus 2 cm resection margin and oncoplastic closure of breast parenchymal defect on immediate postoperative complications, cosmesis and patient satisfaction in women with early breast cancer (T1,T2.N0): A 2 X 2 factorial design randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012288
Enrollment
174
Registered
2018-03-01
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: null- Women with in-situ/invasive breast tumours â?¤ 4 cm or less in their largest diameter

Interventions

Intervention1: wide local excision with 1 cm and 2 cm margin followed by either simple closure or oncoplastic closure of defect: 1.To compare local recurrence, postoperative complications with 2 cm ma

Sponsors

Human Resource Development Group CSIR
Lead Sponsor
AIIMS NEW DELHI
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Women with in-situ/invasive breast tumours <= 4 cm or less in their largest diameter

Exclusion criteria

Exclusion criteria: Patient age of 70 years or older, Multicentric carcinoma of breast, Local failure of previous conservative treatment, Patients who are unable to consent and those not suitable for radiotherapy

Design outcomes

Primary

MeasureTime frame
1. To compare local recurrence, postoperative complications with 2 cm margin of clearance versus 1 cm margin in breast conserving therapy for early breast cancer ( upto 4 cm) 2. To compare postoperative complications and patient satisfaction with oncoplastic closure versus simple closure of breast parenchymal defect in breast conserving therapy. 3. To evaluate the effect of neoadjuvant chemotherapy on postoperative complications Timepoint: 3 years—

Secondary

MeasureTime frame
1.CosmesisTimepoint: 3 years—

Countries

India

Contacts

Public ContactProf Anurag Srivastava

AIIMS,NEW DELHI

mcmisra@gmail.com9868397729

Outcome results

None listed

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