NCT05782686

Impact of Systematic Shaving on Margins

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Margin, Tumor-Free
• Breast Cancer
• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-07
• Primary completion: 2026-06-16
• Completion: 2026-10-16
• First posted: 2023-03-23
• Last updated: 2025-09-15

Locations

1 site across 1 country: Spain