Impact of Systematic Shaving on Margins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Margin shaving.
- Who it may be relevant to
- Registry conditions: Margin, Tumor-Free, Breast Cancer, Surgery. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room
Overview
The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.
Detailed description
Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving/no-shaving (standard surgery).
Interventions
- Procedure Margin shaving
In both cohorts, an intraoperative study of the margins will be carried out, and enlargement of those margins that are affected will be carried out as indicated by the pathologist. Subsequently, shaving is performed in case of being randomized to the study group or surgery is completed in the control group.
Primary outcome measures
- Margin involvement [Time frame: 3 weeks after each surgery]
- Re-interventions [Time frame: 3 weeks after each surgery]
Secondary outcome measures (1)
- Shaving versus intraoperative pathological study [Time frame: 3 weeks after each surgery]
Eligibility criteria
Inclusion criteria
- Breast-conserving surgery.
- Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance;
- Pathological diagnosis of carcinoma in situ or infiltrating
- Oncoplastic without associated flaps;
Exclusion criteria
- Male patients;
- Patients with a history of ipsilateral breast cancer.
- Oncoplastic that includes flaps
- Multifocality or multicentricity;
- Pregnant or lactating patient;
- Stage IV patients;
- Patients eligible for mastectomy;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital de Bellvitge — L'Hospitalet de Llobregat
Identifiers
NCT: NCT05782686 · PR275/20