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

University Hospital Basel

Status: Active, not recruiting

Conditions: Breast Reconstruction; Implant-Based Breast Reconstruction (IBBR)

Treatments: Procedure: sub-pectoral IBBR; Procedure: pre-pectoral IBBR

Study type: Interventional

Funder types: Other

Identifiers

NCT04293146

2020-00256 ch18Weber4;

Details and patient eligibility

About

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.

Full description

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.The aim is to adhere to standard of care as much as possible to follow the pragmatic trial design to generate data that are applicable to today's practice. Therefore, surgeons are allowed to use their preferred Acellular Dermal Matrix (ADM), synthetic meshes, expanders and implants, thereby offering practitioners considerable leeway in deciding how to perform the procedure. For the same reason, both the one- and two-staged IBBR approaches are allowed when studying pre- versus sub-pectoral IBBR.

Enrollment: 382 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent according to ICH/GCP regulations prior to any trial specific procedures
• Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting
• Ability to complete the Quality of Life questionnaires

Exclusion criteria

• No indication for IBBR according to clinical judgment of the treating surgeon
• Skin flaps inadequate for pre-pectoral IBBR.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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382 participants in 2 patient groups

pre-pectoral IBBR

Active Comparator group

Treatment:

Procedure: pre-pectoral IBBR

sub-pectoral IBBR

Active Comparator group

Treatment:

Procedure: sub-pectoral IBBR