Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer

Not Applicable

Completed

• Conditions: Breast Conserving Surgery

• Registration Number: NCT04092842
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The placement of a small silicone prosthesis in the partial defects generated by conservative breast cancer surgery improves the aesthetic result, compared to the usual surgical technique, in a safe and reproducible way and compatible with adjuvant treatments. It could also potentially improve the quality of life of patients

Detailed Description

Conservative surgery in breast cancer is performed more than 50% of cases, however, aesthetic results are suboptimal, because reconstructive techniques are performed in less than 5% of them. Objective: To demonstrate that the placement of a silicone prosthesis in partial defects generated by breast cancer conservative surgery improves the aesthetic result, compared to the usual surgical technique, safely, reproducibly and compatible with adjuvant treatments.

Methodology: Prospective randomized clinical trial, controlled with blind evaluator. Inclusion criteria: Women with breast cancer candidates for conservative surgery. Intervention: In the cases the study technique will be carried out consisting in the filling of the defect with a silicone prosthesis of size adjusted to it (2-4cm). Controls: usual surgical procedure. Main result variable: aesthetic results (visual analog scale) according to the patient, surgeon and blind external evaluator. Secondary variables: surgical complications, local complications derived from adjuvant treatments, rate of local recurrence, rate of reintervention due to affected margins, behavior in mammographic follow-up, professional satisfaction and impact on quality of life.

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-17
• Study Start: 2019-09-18
• Primary Completion: 2021-07-29
• Study Completion: 2022-03-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women, over 18 years old, with breast cancer who attend breast pathology consultations at the Sant Pau Hospital in which conservative surgery is indicated.

Exclusion Criteria

• Multicentric tumors
• Tumors larger than 5cm
• Locally advanced tumors (T4): Deep plane involvement or skin involvement
• Patients in stages IV (distance dissemination)
• Patients who need mastectomy
• Patients with disabilities or who do not understand the terms of the study or do not agree to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Aesthetic result	4 weeks	Aesthetic result of the new technique by applying a visual analog scale for measuring patient satisfaction.; Scale ranges: minimum score: 0 (no satisfaction - worse outcome), maximum score: 10 (total satisfaction - better outcome)

Secondary Outcome Measures

Name	Time	Method
Surgical complications	4 weeks	Incidence of surgical complications.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain