Breast CancerNCT07059104
Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study
An observational study of Breast Cancer and Breast Reconstruction, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction, Bariatric Surgery
- What is being tested?
- Breast augmentation and Breast reconstruction after mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 31 Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who have weight loss surgery and then have breast reconstruction.
Who may be able to join
- Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Västra Götalandsregionen
Gothenburg
Emma Hansson, Professor, MD, PhD, +46313421000, emma.em.hansson@vgregion.se
About this study
Official title: Implant-based Breast Surgery and Reconstruction Following Bariatric Surgery: an Observational Register-based Study on Prevalence and Risk Factors for Surgical Complications
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:
- 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?
- 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)?
- 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.
- 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.
- 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.
- 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?
Read more
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.
- Conditions
- Breast Cancer, Breast Reconstruction, Bariatric Surgery, Breast Implant, Breast Implant Infection, Surgical Complication
- Being tested
- Breast augmentation, Breast reconstruction after mastectomy
- Keywords
- plastic surgery, breast augmentation, breast implant, augmentation mastopexy, complications, post-bariatric reconstruction
- Medical subject headings
- Breast Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast augmentationProcedure or surgery
Also called Breast enlargement, Augmentation mastopexy, breast implant, post-bariatric breast reconstruction
Breast augmentation with an implant
Breast reconstruction after mastectomyProcedure or surgery
Also called DIEP flap, implant-based breast reconstruction, risk reducing mastectomy, immediate breast reconstruction
Breast reconstruction after mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Breast implant after weight loss surgery | Women who have had weight loss surgery and are having breast plastic surgery (benign) Receives: Procedure: Breast augmentation | |
| Breast implant controls | Women who have not had weight loss surgery and are having breast plastic surgery (benign) Receives: Procedure: Breast augmentation | |
| Breast reconstruction after weight loss surgery | Women who have had weight loss surgery and are having breast reconstruction after mastectomy (malignant)
Subgroups: therapeutic mastectomies, risk-reducing mastectomies,immediate breast reconstruction, delayed breast reconstruction. Receives: Procedure: Breast reconstruction after mastectomy | |
| Breast reconstruction controls | Women who have not had weight loss surgery and are having breast reconstruction after mastectomy (malignant).Subgroups: therapeutic mastectomies, risk-reducing mastectomies, immediate breast reconstruction, delayed breast reconstruction. Receives: Procedure: Breast reconstruction after mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of breast plastic surgery following bariatric surgery
How many of the women who have bariatric surgery later have breast plastic surgery according to national registries.
Measured: 10 years. The time frame is longer than the study duration, as it is based on already collected registry-based data.
Demography
Demography 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)
Measured: 3 months
Surgical details
All surgical details given in BRIMP and in NKBC, eg type of implant, type of reconstruction etc.
Measured: 3 months
Complications and risk factors for complications
Complications following the surgery and risk factors as defined in the national registers.
Measured: 10 years
Re-operations and risk factors for re-operations
Any re-operations and risk factors registered in the national registries.
Measured: 10 years
Secondary outcomes (1)
Drugs
Usage of anticoagulants, pain killers, and antibiotics 3 months before and 3 months after the breast operation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emma Hansson, professor, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059104
- Sponsor's protocol ID
- 284398
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansson E, Li Y, Grimby-Ekman A, Elander A, Paganini A. Nomogram Risk Prediction Model for Reoperation/Revision in the First 5 Years After Primary Breast Augmentation Following Massive Weight Loss: A Clinical Tool. Aesthet Surg J. 2026 Mar 2;46(3):284-290. doi: 10.1093/asj/sjaf234.
PubMed 41219167Paganini A, Ottosson J, Halle M, Mirzaei N, Gudbjornsdottir S, Grimby-Ekman A, Hansson E. Frequency, demographics, and comorbidity of women with post-bariatric breast implants: A Swedish population-based controlled study. J Plast Reconstr Aesthet Surg. 2025 Dec;111:145-155. doi: 10.1016/j.bjps.2025.10.004. Epub 2025 Oct 8.
PubMed 41151312
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant-based Breast Surgery and Reconstruction Following Bariatric Surgery: an Observational Register-based Study on Prevalence and Risk Factors for Surgical Complications
- ClinicalTrials.gov ID
- NCT07059104
- Acronym / sponsor ID
- 284398
- Conditions
- Breast Cancer, Breast Reconstruction, Bariatric Surgery, Breast Implant, Breast Implant Infection, Surgical Complication
- Keywords
- plastic surgery, breast augmentation, breast implant, augmentation mastopexy, complications, post-bariatric reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jul 2025 (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.
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:
- 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?
- 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)?
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breast implant after weight loss surgery | – | Procedure: Breast augmentationWomen who have had weight loss surgery and are having breast plastic surgery (benign) |
| Breast implant controls | – | Procedure: Breast augmentationWomen who have not had weight loss surgery and are having breast plastic surgery (benign) |
| Breast reconstruction after weight loss surgery | – | Procedure: Breast reconstruction after mastectomyWomen who have had weight loss surgery and are having breast reconstruction after mastectomy (malignant) Subgroups: therapeutic mastectomies, risk-reducing mastectomies,immediate breast reconstruction, delayed breast reconstruction. |
| Breast reconstruction controls | – | Procedure: Breast reconstruction after mastectomyWomen who have not had weight loss surgery and are having breast reconstruction after mastectomy (malignant).Subgroups: therapeutic mastectomies, risk-reducing mastectomies, immediate breast reconstruction, delayed breast reconstruction. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who have weight loss surgery and then have breast reconstruction.
Key inclusion criteria (1 listed)
- Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast augmentationAlso: Breast enlargement, Augmentation mastopexy, breast implant, post-bariatric breast reconstructionBreast augmentation with an implant | Procedure or surgery | Breast implant after weight loss surgery, Breast implant controls |
| Breast reconstruction after mastectomyAlso: DIEP flap, implant-based breast reconstruction, risk reducing mastectomy, immediate breast reconstructionBreast reconstruction after mastectomy | Procedure or surgery | Breast reconstruction after weight loss surgery, Breast reconstruction controls |
Primary outcome
Frequency of breast plastic surgery following bariatric surgery
Time frame: 10 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.
Demography
Time frame: 3 months
Demography 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 details
Time frame: 3 months
All surgical details given in BRIMP and in NKBC, eg type of implant, type of reconstruction etc.
Complications and risk factors for complications
Time frame: 10 years
Complications following the surgery and risk factors as defined in the national registers.
Re-operations and risk factors for re-operations
Time frame: 10 years
Any re-operations and risk factors registered in the national registries.
1 secondary outcome
Drugs
Time frame: 6 months
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 16 Jul 2025.
- Derived from this study: PubMed 41219167Hansson E, Li Y, Grimby-Ekman A, Elander A, Paganini A. Nomogram Risk Prediction Model for Reoperation/Revision in the First 5 Years After Primary Breast Augmentation Following Massive Weight Loss: A Clinical Tool. Aesthet Surg J. 2026 Mar 2;46(3):284-290. doi: 10.1093/asj/sjaf234.
- Derived from this study: PubMed 41151312Paganini A, Ottosson J, Halle M, Mirzaei N, Gudbjornsdottir S, Grimby-Ekman A, Hansson E. Frequency, demographics, and comorbidity of women with post-bariatric breast implants: A Swedish population-based controlled study. J Plast Reconstr Aesthet Surg. 2025 Dec;111:145-155. doi: 10.1016/j.bjps.2025.10.004. Epub 2025 Oct 8.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Emma Hansson, professor, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Reconstruction, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Hansson, Professor, MD, Phd, MA (+46313421000, emma.em.hansson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of breast plastic surgery following bariatric surgery (time frame: 10 years. The time frame is longer than the study duration, as it is based on already collected registry-based data.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07059104, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.