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Impact of Systematic Shaving on Margins

NCT05782686 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2025-09-15

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Amparo Garcia Tejedor, MDPhD · Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2026-06-16
Completion
2026-10-16

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05782686 on ClinicalTrials.gov