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Procedure

Pre- vs Sub-Pectoral Breast Reconstruction for Breast Reconstruction (OPBC-02PREPEC Trial)

N/A

Waitlist Available

Led By Walter Weber, Prof. Dr. med

Research Sponsored by University Hospital, Basel, Switzerland

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 24 months since mastectomy

Awards & highlights

OPBC-02PREPEC Trial Summary

This trial is to see if a different way of doing breast reconstruction surgery provides better quality of life for patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include pain, swelling, infection risk at surgery site, possible issues with implant like rupture or displacement, and differences in sensation around reconstructed area.

OPBC-02PREPEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

OPBC-02PREPEC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in BREAST-Q scale

Change in EQ-5D-5L questionnaire

Secondary outcome measures

Recurrence-free survival (RFS)

aesthetic results

aesthetic results evaluated by local physicians

+10 more

OPBC-02PREPEC Trial Design

2Treatment groups

Active Control

Group I: pre-pectoral IBBRActive Control1 Intervention

Group II: sub-pectoral IBBRActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Hospital, Basel, SwitzerlandLead Sponsor

964 Previous Clinical Trials

1,853,959 Total Patients Enrolled

Swiss National Science FoundationOTHER

221 Previous Clinical Trials

453,214 Total Patients Enrolled

Walter Weber, Prof. Dr. medPrincipal InvestigatorDivision of Breast Surgery, University Hospital Basel

Media Library

pre-pectoral IBBR (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04293146 — N/A

Implant-Based Breast Reconstruction Research Study Groups: pre-pectoral IBBR, sub-pectoral IBBR

Implant-Based Breast Reconstruction Clinical Trial 2023: pre-pectoral IBBR Highlights & Side Effects. Trial Name: NCT04293146 — N/A

pre-pectoral IBBR (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04293146 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the bounding extent of participants in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was published on July 28th 2020, is actively recruiting participants. The study seeks to recruit 372 individuals from one location."

Answered by AI

Is enrollment in this clinical trial currently available to the public?

"Affirmative. According to information made available on clinicaltrials.gov, this research effort is currently recruiting participants. It was initially posted on July 28th 2020 and last modified on November 1st 2021; 372 patients are expected to be recruited from a single site."

Answered by AI

What is the purpose of this experimentation?

"The primary metric for evaluating the efficacy of this clinical trial is Change in BREAST-Q scale. This will be measured over a 24 month period, commencing with screening and continuing through day 10 as well as months 1, 6, 12 and 24. Secondary outcomes include length of hospital stay (index hospitalization and overall) following randomization until discharge; number of outpatient visits at either the trial site or emergency department; and surgical complications such as Wound dehiscence, Haematoma, Seroma, Implant/expander exposure/Extrusion amongst others."

Answered by AI