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

Breast Conserving Surgery Clinical Trial

— PROSILMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092842
• Other study ID #: IIBSP-SIL-2017-70
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Conserving Surgery

Intervention

Device:
• Silicone prosthesis
Silicone prosthesis

Procedure:
• Usual practice
Usual surgery

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aesthetic result	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)	4 weeks
Secondary	Surgical complications	Incidence of surgical complications.	4 weeks