Autologous vs. Implant-based Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2031-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference trial (RPPT) might be a way to overcome these challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose method. The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised. In the preference cohort patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60-months. Embedded qualitative studies and within-trial economic evaluation will be performed.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?

NCT02637635

Breast Neoplasms

UNKNOWN NA

Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction

NCT03959709

Mastectomy Breast Cancer

UNKNOWN NA

Direct to Implant Breast Reconstruction Based Pre- or Retropectoral

NCT03143335

Breast Reconstruction

UNKNOWN NA

Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)

NCT05363189

Breast Reconstruction Breast Cancer

RECRUITING

Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction

NCT07230535

Breast Cancer, Breast Neoplasms Breast Reconstruction DIEP Flap Breast Reconstruction +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Randomised DIEP flap

Group Type ACTIVE_COMPARATOR

DIEP-flap

Intervention Type PROCEDURE

Breast reconstruction with a deep inferior epigastric perforator flap

Randomised implant-based

Group Type ACTIVE_COMPARATOR

Implant

Intervention Type PROCEDURE

Breast reconstruction with an implant-based technique

Preference DIEP-flap

Group Type ACTIVE_COMPARATOR

DIEP-flap

Intervention Type PROCEDURE

Breast reconstruction with a deep inferior epigastric perforator flap

Preference implant-based

Group Type ACTIVE_COMPARATOR

Implant

Intervention Type PROCEDURE

Breast reconstruction with an implant-based technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DIEP-flap

Breast reconstruction with a deep inferior epigastric perforator flap

Intervention Type PROCEDURE

Implant

Breast reconstruction with an implant-based technique

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Biological female
* \>18 years of age
* American Society of anesthesiologist classification (ASA) 1-2
* Patient must have had or be scheduled for a mastectomy
* Ability to give informed consent
* Ability to communicate in Swedish

Exclusion Criteria

* ASA \> 2
* BMI \> 30 kg/m2
* Smoking1 radiotherapy to the breast in question.
* Radiotherapy is expected post-operatively.
* Locally advanced breast cancer
* Metastasised breast cancer
* Comorbidity and/or drugs that affect wound healing.
* Unstable psychiatric co-morbidity
* Abdominal scaring/chest scaring making a DIEP/implant-based reconstruction unsuitable

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No