Impact of Systematic Shaving on Margins

September 14, 2026 updated by: Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge

Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Breast-conserving surgery.
  2. Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance;
  3. Pathological diagnosis of carcinoma in situ or infiltrating
  4. Oncoplastic without associated flaps;

Exclusion Criteria:

  1. Male patients;
  2. Patients with a history of ipsilateral breast cancer.
  3. Oncoplastic that includes flaps
  4. Multifocality or multicentricity;
  5. Pregnant or lactating patient;
  6. Stage IV patients;
  7. Patients eligible for mastectomy;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shaving
Subsequent to lumpectomy, a circumferential enlargement of all lumpectomy margins, including lateral, medial, superior, inferior, anterior, and posterior, approximately 5-10mm thick, will be resected.
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.
Active Comparator: No Shaving
Standard lumpectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Margin involvement
Time Frame: 3 weeks after each surgery
To compare the number of cases with affected margins in the definitive pathological anatomy, of the cases with intraoperative systematic shaving versus the group of no shaving
3 weeks after each surgery
Re-interventions
Time Frame: 3 weeks after each surgery
Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique
3 weeks after each surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shaving versus intraoperative pathological study
Time Frame: 3 weeks after each surgery
Assess the possibility of replacing the intraoperative study of the margins with systematic shaving
3 weeks after each surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Estimated)

June 16, 2027

Study Completion (Estimated)

October 16, 2027

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR275/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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