Active — Not RecruitingNot Applicable

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

United States, Austria, Germany382 participantsStarted 2020-07-28

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in BREAST-Q scale

Timeframe: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)

Change in EQ-5D-5L questionnaire

Timeframe: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)

Trial details

NCT IDNCT04293146

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05

View on ClinicalTrials.gov More Breast Reconstruction trials