Implant-based breast reconstruction after bariatric (weight-loss) surgery
Implant-based Breast Surgery and Reconstruction Following Bariatric Surgery: an Observational Register-based Study on Prevalence and Risk Factors for Surgical Complications
This registry-based project will use national data to see how common breast implants are and whether women who've had bariatric weight-loss surgery have different complication rates after implant-based breast augmentation or reconstruction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Sex | Female |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT07059104 on ClinicalTrials.gov |
What this trial studies
This is an observational, registry-based national analysis using the Swedish Soreg registry with linkage to BRIMP and NKBC to identify women who received implant-based breast augmentation or reconstruction and to capture surgical details and complications. The study will compare the proportion of women with implants and describe demographic and operative characteristics, including incision type and implant features (texture, shape, size). It will compare complication rates and surgical characteristics between women with prior bariatric surgery and other women, and will specifically examine delayed reconstruction after mastectomy. Data are derived from routine surgical registries rather than an interventional protocol, enabling large-scale population comparisons.
Who should consider this trial
Good fit: Women who have undergone bariatric (weight-loss) surgery and later receive implant-based breast augmentation or implant-based reconstruction who are recorded in the Swedish Soreg registry and in BRIMP or NKBC.
Not a fit: Women who are not captured in the specified Swedish registries, who receive non-implant (autologous) reconstruction, or who are male will not be represented and are unlikely to benefit directly from the study's findings.
Why it matters
Potential benefit: If successful, the findings could help surgeons and patients better predict complication risk and choose surgical/implant options tailored to women with prior bariatric surgery.
How similar studies have performed: Smaller single-center and cohort reports have described outcomes after bariatric surgery and breast procedures, but large national registry comparisons of implant-based reconstruction in this population are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC Exclusion Criteria: \-
Where this trial is running
Gothenburg
- Västra Götalandsregionen — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Emma Hansson, professor, MD, PhD — Sahlgrenska University Hospital
- Study coordinator: Emma Hansson, Professor, MD, Phd, MA
- Email: emma.em.hansson@vgregion.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.