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

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy (OPBC-02/ PREPEC): a Pragmatic, Multicenter, Randomized, Superiority Trial

ClinicalTrials.gov ID

NCT04293146

Acronym / sponsor ID

OPBC-02PREPEC / 2020-00256; ch18Weber4

Conditions

Breast Reconstruction, Implant-Based Breast Reconstruction (IBBR)

Keywords

skin-sparing mastectomy (SSM), nipple-sparing mastectomy (NSM), immediate breast reconstruction, pre-pectoral breast implant, sub-pectoral breast implant

Study type

Interventional

Recruitment status

Active, not recruiting

Enrolment

382 participants (actual)

Lead sponsor

University Hospital, Basel, SwitzerlandUniversity, hospital or other

Collaborators

Swiss National Science Foundation

Study start

28 Jul 2020 (actual)

Primary completion

May 2025 (estimated)

Study completion

Feb 2033 (estimated)

First posted

3 Mar 2020 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Other

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (outcomes assessor)

Number of arms

2

Model description

The study will objectively assess the results and complication of two surgical techniques and thus provide evidence to assess whether there are differences between these techniques.

Who may qualify

Ages

18 years and older

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change in BREAST-Q scale

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

   compare the Quality of Life (QoL) with respect to long-term physical well-being (chest) after pre-pectoral or sub-pectoral IBBR. The BREAST-Q module specific to breast reconstruction version 2.0 consists of 13 independent scales covering health-related QoL domains and satisfaction domains. Each scale is scored to generate a numerical score on a scale from 0 (worst) to 100 (best).

2. Change in EQ-5D-5L questionnaire

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

   The 5-level version of the EQ-5D (EQ-5D-5L) consists of the EQ-5D descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/Depression (5 answer levels each: no problems, slight problems, moderate problems, severe problems and extreme problems), resulting in a 1-digit number that expresses the level for that dimension. The digits for each dimension are combined into a 5-digit number that describes the patient's health state and is subsequently converted into a preference-based quality of life weight (utility) using an algorithm derived from population-based studies. In addition, patients are asked to rate their health on a vertical visual analogue scale (EQ VAS), where the anchors are labelled with 'The best health you can imagine' and 'The worst health you can imagine'.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
• Derived from this study: PubMed 34475143Kappos EA, Schulz A, Regan MM, Moffa G, Harder Y, Ribi K, Potter S, Pusic AL, Fehr MK, Hemkens LG, Holzbach T, Farhadi J, Simonson C, Knauer M, Verstappen R, Bucher HC, Zwahlen D, Zimmermann F, Schwenkglenks M, Mucklow R, Shaw J, Bjelic-Radisic V, Chiorescu A, Chun YS, Farah S, Xiaosong C, Nigard L, Kuemmel S, Reitsamer R, Hauschild M, Fulco I, Tausch C, Fischer T, Sarlos D, Constantinescu MA, Lupatsch JE, Fitzal F, Heil J, Matrai Z, de Boniface J, Kurzeder C, Haug M, Weber WP. 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. 2021 Sep 2;11(9):e045239. doi: 10.1136/bmjopen-2020-045239.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

22 sites in 7 countries: see every site and its status.