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Recruiting NCT06195865

Autologous vs. Implant-based Breast Reconstruction

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DIEP-flap, Implant.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Autologous vs. Implant-based Breast Reconstruction: a Partially Randomised Patient Preference, Superiority Trial

Overview

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.

Interventions

  • Procedure DIEP-flap
    Breast reconstruction with a deep inferior epigastric perforator flap
  • Procedure Implant
    Breast reconstruction with an implant-based technique

Primary outcome measures

  • Satisfaction with the breast/s and breast-specific quality of life [Time frame: 5 years]
  • Cost-effectiveness [Time frame: 5 years+ simulation model based on 20 years]
Secondary outcome measures (7)
  • Complications [Time frame: 5 years]
  • Surgical revisions [Time frame: 5 years]
  • Satisfaction with the donor-site [Time frame: 5 years]
  • Symptoms of depression and anxiety [Time frame: 5 years]
  • Body image [Time frame: 5 years]
  • Body investment [Time frame: 5 years]
  • Generic quality of life [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 2 centers
  • Sahlgrenska university hospital — Gothenburg
  • Sahlgrenska university hospital — Gothenburg

Publications

  • Hansson E, Lofstrand J, Larsson C, Uusimaki A, Svensson K, Ekman A, Svensson M, Paganini A. Gothenburg Breast reconstruction (GoBreast) II protocol: a Swedish partially randomised patient preference, superiority trial comparing autologous and implant-based breast reconstruction. BMJ Open. 2024 Jul 17;14(7):e084025. doi: 10.1136/bmjopen-2024-084025. PMID 39019639

Identifiers

NCT: NCT06195865 · 2023-04754-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗