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Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study

Implant-based Breast Surgery and Reconstruction Following Bariatric Surgery: an Observational Register-based Study on Prevalence and Risk Factors for Surgical Complications

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07059104
Enrollment
20000
Registered
2025-07-10
Start date
2025-01-01
Completion date
2028-12-31
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Breast Cancer, Breast Implant, Breast Implant Infection, Breast Reconstruction, Mastopexy, Surgical Complication, Weight Loss

Keywords

plastic surgery, breast augmentation, breast implant, augmentation mastopexy, complications, post-bariatric reconstruction

Brief summary

The goal of this national registry-based study is to investigate the prevalence of reconstructive breast surgery and risk factors for surgical complications in women who have had weight loss surgery previously. The main questions it aims to answer are: 1. What is the perceived need for breast implants after weight loss surgery, described as the proportion who have breast implants, and what characteristics, in terms of demographics and surgical details, do the operated women have? 2. In women who have breast enlargement or breast enlargement combined with a lift, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example skin incision and choice of implant (for example texture, shape, size)? 3. In women who have delayed breast reconstruction after breast cancer, that is have had their breast/s reconstructed in a separate operation, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation. 4. In women who have immediate breast reconstruction after breast cancer?, that is have a breast reconstruction at the same time as the mastectomy, are there any differences between the women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation. 5. In women who have risk reducing mastectomies, are there any differences between he women who have had weight loss surgery and other women regarding complications after the operation and characteristics of the surgery, for example in technique used (autologous versus implant-based, choice of implant, such as texture, shape and size), and timing of the surgery? Immediate breast reconstruction is defined as performed at the same time as the mastectomy, and delayed as an operation performed later in a separate operation. 6. Are there any identifiable risk factors for complications after breast reconstructive surgery, specific to the women who have had weight loss surgery and other women? Researchers will compare the patients to women who have the same type of reconstructive breast surgery but have not had bariatric surgery previously. The study will use prospectively collected data from seven registers: The Scandinavian Obesity Surgery Register (SOReg), The Swedish Breast Implant Register (BRIMP), the Swedish National Quality Register for Breast Cancer (NKBC), the Swedish National Diabetes Register (NDR), Statistics Sweden (SCB), the Swedish inpatient register, and the Swedish National Prescribed Drug Register.

Interventions

PROCEDUREBreast augmentation

Breast augmentation with an implant

PROCEDUREBreast reconstruction after mastectomy

Breast reconstruction after mastectomy

Sponsors

Vastra Gotaland Region
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Frequency of breast plastic surgery following bariatric surgery10 years. The time frame is longer than the study duration, as it is based on already collected registry-based data.How many of the women who have bariatric surgery later have breast plastic surgery according to national registries.
Demography3 monthsDemography of the patients compared to the controls (eg. age, BMI, education level, income level, marital status, country of origin, county of residence, employment status, co-morbidity, usage of drugs)
Surgical details3 monthsAll surgical details given in BRIMP and in NKBC, eg type of implant, type of reconstruction etc.
Complications and risk factors for complications10 yearsComplications following the surgery and risk factors as defined in the national registers.
Re-operations and risk factors for re-operations10 yearsAny re-operations and risk factors registered in the national registries.

Secondary

MeasureTime frameDescription
Drugs6 monthsUsage of anticoagulants, pain killers, and antibiotics 3 months before and 3 months after the breast operation.

Countries

Sweden

Contacts

Primary ContactEmma Hansson, Professor, MD, Phd, MA
emma.em.hansson@vgregion.se+46313421000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026