382 Participants Needed

Pre- vs Sub-Pectoral Breast Reconstruction for Breast Reconstruction

(OPBC-02PREPEC Trial)

Recruiting at 22 trial locations
WW
MH
Overseen ByMartin Haug, Prof. Dr. med
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University Hospital, Basel, Switzerland
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

WW

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 OverviewThe 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
2Treatment groups
Active Control
Group I: pre-pectoral IBBRActive Control1 Intervention
Group II: sub-pectoral IBBRActive Control1 Intervention

Find a Clinic Near You

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

Advances in Prepectoral Breast Reconstruction. [2023]
Early assessment of post-surgical outcomes with pre-pectoral breast reconstruction: A literature review and meta-analysis. [2022]
Quality of life, pain of prepectoral and subpectoral implant-based breast reconstruction with a discussion on cost: A systematic review and meta-analysis. [2022]
Mastectomy and Immediate Breast Reconstruction with Pre-Pectoral or Sub-Pectoral Implant: Assessing Clinical Practice, Post-Surgical Outcomes, Patient's Satisfaction and Cost. [2023]
Tissue Expander-Based Breast Reconstruction in the Prepectoral Versus Subpectoral Plane: An Analysis of Short-Term Outcomes. [2023]
Comparison of prepectoral and subpectoral breast reconstruction after mastectomies: A systematic review and meta analysis. [2020]
"Prevention of postoperative complications by prepectoral versus subpectoral breast reconstruction: A systematic review and meta-analysis". [2023]
A Comparative Study of Secondary Procedures after Subpectoral and Prepectoral Single-Stage Implant-Based Breast Reconstruction. [2023]
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]