Pre- vs Sub-Pectoral Breast Reconstruction for Breast Reconstruction

(OPBC-02PREPEC Trial)

Recruiting at 22 trial locations

Overseen By Martin Haug, Prof. Dr. med

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Hospital, Basel, Switzerland

Disqualifiers: Inadequate skin flaps, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

382 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{1 3 8 9 10}

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.

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

Written informed consent according to ICH/GCP regulations prior to any trial specific procedures

I am having or had nipple-sparing or skin-sparing mastectomy with immediate breast reconstruction.

Ability to complete the Quality of Life questionnaires

Exclusion Criteria

My skin flaps are not suitable for breast reconstruction over the chest muscle.

My surgeon decided I don't need immediate breast reconstruction.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery and Immediate Reconstruction

Participants undergo mastectomy and immediate implant-based breast reconstruction

1 week

Hospital stay for surgery

Post-operative Follow-up

Participants are monitored for surgical complications and recovery

4 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored for quality of life and safety outcomes

24 months

Visits at months 1, 6, 12, and 24

Treatment Details

Interventions

• pre-pectoral IBBR
• sub-pectoral IBBR

Trial Overview The study compares two types of breast reconstruction after mastectomy: one where the implant is placed under the chest muscle (sub-pectoral), and another where it's placed over the muscle but under the skin (pre-pectoral). The goal is to see which method offers better physical well-being in terms of chest comfort after 24 months.

Participant Groups

Group I: pre-pectoral IBBR Active Control 1 Intervention

Group II: sub-pectoral IBBR Active Control 1 Intervention

Who Is Running the Clinical Trial?

University Hospital, Basel, Switzerland

Lead Sponsor

Trials

1,031

Recruited

2,503,000+

Swiss National Science Foundation

Collaborator

Trials

227

Recruited

457,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Advances in Prepectoral Breast Reconstruction. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Early assessment of post-surgical outcomes with pre-pectoral breast reconstruction: A literature review and meta-analysis. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Quality of life, pain of prepectoral and subpectoral implant-based breast reconstruction with a discussion on cost: A systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mastectomy and Immediate Breast Reconstruction with Pre-Pectoral or Sub-Pectoral Implant: Assessing Clinical Practice, Post-Surgical Outcomes, Patient's Satisfaction and Cost. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Tissue Expander-Based Breast Reconstruction in the Prepectoral Versus Subpectoral Plane: An Analysis of Short-Term Outcomes. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of prepectoral and subpectoral breast reconstruction after mastectomies: A systematic review and meta analysis. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

"Prevention of postoperative complications by prepectoral versus subpectoral breast reconstruction: A systematic review and meta-analysis". [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Comparative Study of Secondary Procedures after Subpectoral and Prepectoral Single-Stage Implant-Based Breast Reconstruction. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

One-Step Prepectoral Breast Reconstruction With Dermal Matrix-Covered Implant Compared to Submuscular Implantation: Functional and Cost Evaluation. [2022]

10. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Acellular dermal matrix in implant-based immediate breast reconstructions: a comparison of prepectoral and subpectoral approach. [2022]