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Is intraoperative ultrasound guided breast conservation surgery for breast cancer better than conventional one?

COMPARISON OF CONVENTIONAL VS INTRAOPERATIVE ULTRASOUND GUIDED WIDE LOCAL EXCISION OF MALIGNANT BREAST LUMP IN TERMS OF MARGIN POSITIVITY AND COSMESIS - A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010576
Enrollment
60
Registered
2017-11-21
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- Carcinoma breast

Interventions

Intervention1: Palpation guided group: Patients undergoing palpation guided breast conservation surgery Control Intervention1: Ultrasound guided surgery: Patients undergoing ultrasound guided breast c

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Carcinoma breast amenable to breast conservation surgery a. Patients of primary carcinoma breast with palpable T1/T2 lesion b. Breast cancer down staged by neoadjuvant chemotherapy so as to be amenable to BCS 2. Patients willing for breast conservation. 3. Patients consenting for the study.

Exclusion criteria

Exclusion criteria: 1. Patients not desirous of breast conservation. 2. Patients with T3/N1 or more advanced disease in spite of neoadjuvant chemotherapy (poor response). 3. Patients not consenting to participate in the study. 4. Patients in whom BCS is contraindicated like multicentric tumor, previous radiotherapy, pregnancy, poor tumor to breast ratio 5. Patients with severe co morbidities precluding fitness for General Anesthesia.

Design outcomes

Primary

MeasureTime frame
1. To assess margin positivity rates in patients undergoing breast conservation surgery by conventional intra-operative palpation of tumor method and its comparison with intra-operative ultrasound guidance method. 2. To assess cosmesis in patients undergoing breast conservation surgery by conventional palpation of tumor method and its comparison with intra-operative ultrasound guidance method. 3. To look at reduction, if any, in rates of revision surgeries Timepoint: Assessment of margins on arrival of Histopathology report of operative specimen. Assessment of cosmesis at 7 days post operative period and at 3 months

Secondary

MeasureTime frame
1.To assess cosmesis in patients undergoing breast conservation surgery by conventional palpation of tumor method and its comparison with intra-operative ultrasound guidance method. 2. To look at reduction, if any, in rates of revision surgeriesTimepoint: Assessment of margins on arrival of Histopathology report of operative specimen. Assessment of cosmesis at 7 days post operative period and at 3 months

Countries

India

Contacts

Public ContactTejas Prakash Vispute

AIIMS, New Delhi

varnaseenu@hotmail.com9910834455

Outcome results

None listed

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