NCT04642508

The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction

The PreQ-20 TRIAL, a Prospective Cohort Study of the Oncologic Safety, Quality of Life and Cosmetic Outcomes of Patients Undergoing Prepectoral Breast Reconstruction

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: University Hospital A Coruña · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of prepectoral breast reconstruction in women with breast cancer and high risk. The study's main objective is to assess the safety of prepectoral breast reconstruction in terms of postsurgical complications and the feasibility of reconstruction (loss of implants). The secondary objectives are to evaluate oncologic safety (local relapses, residual glandular tissue) and to identify factors related to quality of life and cosmetic sequelae. The evaluation of residual tissue will be conducted by magnetic resonance imaging 12 to 18 months after the surgery, and the quality-of-life assessment will be performed using the BreastQ questionnaire. An initial patient evaluation will be conducted 12-18 months after the surgery, and a second evaluation will be performed at 5 years. The estimated sample size is 81 patients.

Detailed description

1. Mastectomy technique. The breast removal will be performed using a mastectomy adapted to the breast and optimizing the preservation of the breast's original elements (inframammary fold, skin envelope, fat transitions, nipple-areolar complex) according to each patient's anatomical and oncologic possibilities. 2. Reconstruction technique. The reconstruction will be performed by placing a silicone implant coated with polyurethane foam in the prepectoral position. 3. Preoperative assessment. All patients will be assessed by a surgeon of the breast unit. The decision for the mastectomy will be made in consensus with the multidisciplinary committee. Before the surgery, the patients will undergo a mammography and magnetic resonance imaging to confirm the tumor size and rule out multifocality/multicentricity, as well as an evaluation of the distribution of glandular tissue and transitions between the breast and chest wall. 4. Breast magnetic resonance imaging. This study will employ the first magnetic resonance imaging during the postoperative period (between 12 and 18 months) to assess the residual glandular tissue following the mastectomy. 5. BreastQ questionnaire. The BreastQ questionnaire is aimed at evaluating patient-reported satisfaction and quality of life through the use of breast reconstruction modules. The preoperative format, which is delivered to patients before the surgery, and the postoperative format, which is delivered to them 12-18 months after the surgery. Likewise, we will conduct a second postoperative assessment at 5 years of the surgery. d. Images. The evaluation of the cosmetic sequelae requires taking photographs of the patient's chest (from the suprasternal notch to navel). Photographs will be taken prior to the surgery (frontal, right and left lateral), then again at 12-18 months and finally at 5 years of the surgery.

Conditions

• Breast Cancer
• Quality of Life
• Surgery--Complications

Interventions

Type	Name	Description
PROCEDURE	Prepectoral reconstruction	Immediate prepectoral breast reconstruction in women requiring a mastectomy

Timeline

• Start date: 2020-06-22
• Primary completion: 2023-11-01
• Completion: 2026-12-01
• First posted: 2020-11-24
• Last updated: 2023-06-06

Locations

1 site across 1 country: Spain