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Clinical Trials/NCT07059104
NCT07059104RecruitingNot Applicable

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

Vastra Gotaland Region1 site in 1 country20,000 target enrollmentStarted: January 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20,000
Locations
1
Primary Endpoint
Surgical details

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Inclusion in Soreg and thereafter inclusion in either BRIMP or NKBC

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Surgical details

Time Frame: 3 months

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

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)

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.

Secondary Outcomes

  • Drugs(6 months)

Investigators

Sponsor
Vastra Gotaland Region
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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