MedTrace Logo

Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC

NCT04293146 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2024-12-13

No results posted yet for this study

Summary

This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.

Conditions

  • Breast Reconstruction
  • Implant-Based Breast Reconstruction (IBBR)

Interventions

PROCEDURE

pre-pectoral IBBR

The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.

PROCEDURE

sub-pectoral IBBR

The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Walter Weber, Prof. Dr. med · Division of Breast Surgery, University Hospital Basel

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2025-05-31
Completion
2033-02-28

Countries

  • United States
  • Austria
  • Germany
  • Hungary
  • Italy
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293146 on ClinicalTrials.gov