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Ambulatory SNP under local anaesthesia in a subgroup of breast cancer patients - trial

Completed
Conditions
breast cancer
10006291
Registration Number
NL-OMON40766
Lead Sponsor
Medisch Centrum Alkmaar
Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
12
Inclusion Criteria

- Female
- Age 18-60 years
- Diagnosis of invasive breast cancer
- Breast carcinoma measures >20 mm ultrasonographically
- Pre-operative axillary ultrasound (+ fine needle aspiration cytology) is negative or inconclusive
- No evidence of distant metastases
- Signed informed consent

Exclusion Criteria

- History of previous breast surgery in the affected breast
- History of previous axillary surgery in the ipsilateral axilla
- History of radiation therapy (affected breast of axilla)
- History of neo-adjuvant therapy (for the breast cancer)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary outcome parameters are the number of operations under general<br /><br>anaesthesia per patient and the number of operations under local anaesthesia<br /><br>per patient.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcome parameters are Quality of Life, experienced depressive<br /><br>symptoms and anxiety.</p><br>
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