Eligibility
18+
Female
What conditions do you have?
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Study Summary
This trial is to see if a different way of doing breast reconstruction surgery provides better quality of life for patients.
Eligible Conditions
- Breast
- Implant-Based Breast Reconstruction (IBBR)
Treatment Effectiveness
Effectiveness Progress
Other trials for Breast
Study Objectives
2 Primary · 13 Secondary · Reporting Duration: over 24 months since mastectomy
Month 24
aesthetic results evaluated by local physicians
aesthetic results evaluated by patients
Month 24
aesthetic results
animation deformity
capsular contracture
Month 24
total number of outpatient visits at the trial site and the emergency department
Month 24
patient satisfaction
Year 10
Recurrence-free survival (RFS)
Month 24
total number of operative procedures
Month 24
length of hospital stay (index hospitalization and overall)
Month 24
Change in BREAST-Q scale
Change in EQ-5D-5L questionnaire
Month 24
loss of expander or implant
surgical complications
thromboembolic events
Trial Safety
Safety Progress
Other trials for Breast
Trial Design
2 Treatment Groups
pre-pectoral IBBR
1 of 2
sub-pectoral IBBR
1 of 2
Active Control
372 Total Participants · 2 Treatment Groups
Primary Treatment: pre-pectoral IBBR · No Placebo Group · N/A
pre-pectoral IBBR
Procedure
ActiveComparator Group · 1 Intervention: pre-pectoral IBBR · Intervention Types: Proceduresub-pectoral IBBR
Procedure
ActiveComparator Group · 1 Intervention: sub-pectoral IBBR · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 24 months since mastectomy
Who is running the clinical trial?
Swiss National Science FoundationOTHER
204 Previous Clinical Trials
450,631 Total Patients Enrolled
University Hospital, Basel, SwitzerlandLead Sponsor
874 Previous Clinical Trials
2,099,378 Total Patients Enrolled
Walter Weber, Prof. Dr. medPrincipal InvestigatorDivision of Breast Surgery, University Hospital Basel
Eligibility Criteria
Age 18+ · Female Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have given informed consent according to ICH/GCP regulations prior to any trial specific procedures.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Kappos, Elisabeth A, Alexandra Schulz, Meredith M Regan, Giusi Moffa, Yves Harder, Karin Ribi, Shelley Potter, et al.. 2021. “Prepectoral Versus Subpectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy (OPBC-02/ PREPEC): A Pragmatic, Multicentre, Randomised, Superiority Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-045239.
- 2020. "Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04293146.
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