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

Not Applicable
Completed
Conditions
Health Condition 1: null- Carcinoma breast
Registration Number
CTRI/2017/11/010576
Lead Sponsor
All India Institute of Medical Sciences New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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. <br/ ><br>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. <br/ ><br>3.To look at reduction, if any, in rates of revision surgeries <br/ ><br>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 Outcome Measures
NameTimeMethod
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. <br/ ><br>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
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