Pre- vs Sub-Pectoral Breast Reconstruction for Breast Reconstruction
(OPBC-02PREPEC Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of this treatment for breast reconstruction?
Research shows that pre-pectoral breast reconstruction may lead to lower short-term complications and quicker recovery compared to sub-pectoral reconstruction. Additionally, patient satisfaction tends to be higher with pre-pectoral reconstruction, although both methods have similar complication rates.12345
Is pre-pectoral or sub-pectoral breast reconstruction safe?
Both pre-pectoral and sub-pectoral breast reconstruction methods have similar complication rates, with pre-pectoral reconstruction showing some improvements in safety due to advances in materials and techniques. Complication rates for both methods are relatively low, and there is no significant difference in safety between the two approaches.13467
How does pre-pectoral breast reconstruction differ from sub-pectoral breast reconstruction?
Pre-pectoral breast reconstruction places the implant above the chest muscle, which can reduce pain and recovery time compared to the traditional sub-pectoral method where the implant is placed under the muscle. Advances in materials and surgical techniques have made pre-pectoral reconstruction a safer and more attractive option, offering potential benefits in terms of aesthetics and fewer functional issues.138910
Research Team
Walter Weber, Prof. Dr. med
Principal Investigator
Division of Breast Surgery, University Hospital Basel
Eligibility Criteria
This trial is for patients who are having a skin-sparing or nipple-sparing mastectomy and opting for Implant-Based Breast Reconstruction (IBBR) as treatment or prevention of breast cancer. Participants must be able to fill out Quality of Life questionnaires and give informed consent. Those without a clinical need for IBBR or with inadequate skin flaps for pre-pectoral IBBR cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Immediate Reconstruction
Participants undergo mastectomy and immediate implant-based breast reconstruction
Post-operative Follow-up
Participants are monitored for surgical complications and recovery
Long-term Follow-up
Participants are monitored for quality of life and safety outcomes
Treatment Details
Interventions
- pre-pectoral IBBR
- sub-pectoral IBBR
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospital, Basel, Switzerland
Lead Sponsor
Swiss National Science Foundation
Collaborator