Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07059104

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC

Exclusion criteria

-

Treatment and study plan

Breast augmentation

Procedure

Breast augmentation with an implant

Other names: Breast enlargement, Augmentation mastopexy, breast implant, post-bariatric breast reconstruction

Breast reconstruction after mastectomy

Procedure

Breast reconstruction after mastectomy

Other names: DIEP flap, implant-based breast reconstruction, risk reducing mastectomy, immediate breast reconstruction, delayed breast reconstruction, autologous breast reconstruction, therapeutic mastectomy

Primary outcomes

  1. 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.

  2. 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)

  3. Surgical details

    Time frame: 3 months

    All surgical details given in BRIMP and in NKBC, eg type of implant, type of reconstruction etc.

  4. Complications and risk factors for complications

    Time frame: 10 years

    Complications following the surgery and risk factors as defined in the national registers.

  5. Re-operations and risk factors for re-operations

    Time frame: 10 years

    Any re-operations and risk factors registered in the national registries.

Secondary outcomes

  1. Drugs

    Time frame: 6 months

    Usage of anticoagulants, pain killers, and antibiotics 3 months before and 3 months after the breast operation.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Hansson, Professor, MD, Phd, MA

CONTACT

[email protected]

+46313421000

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.