Autologous vs. Implant-based Breast Reconstruction

NCT06195865 | Recruiting

• 1 other identifier: 2023-04754-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast reconstruction; DIEP-flap; Implant-based breast reconstruction

Outcome Measures

Primary Outcomes (2)

• Satisfaction with the breast/s and breast-specific quality of life

  Satisfaction with the breast/s and breast-specific quality of life measured with BREAST-Q reconstruction.The patient rates all items on 3-, 4-, and 5-point Likert-scales. A raw score, that is converted to a score 0-100, is calculated for each domain. A higher score indicates a greater satisfaction or better quality of life.

  5 years

• Cost-effectiveness

  The net cost divided for society by changes in health outcomes measured with Breast-Q and EQ5D.

  5 years+ simulation model based on 20 years

Secondary Outcomes (7)

• Complications

  5 years

• Surgical revisions

  5 years

• Satisfaction with the donor-site

  5 years

• Symptoms of depression and anxiety

  5 years

• Body image

  5 years

Other Outcomes (6)

• Expectations

  Pre-op

• Patient's goals with the reconstruction

  Pre-op

• Study with a trial (SWAT):The choice of breast reconstruction and the choice of reconstructive method.

  Longitudinal - the same participants will be interviewed at allocation and 12 months after the reconstruction.

Study Arms (4)

Randomised DIEP flap

ACTIVE COMPARATOR

Procedure: DIEP-flap

Randomised implant-based

ACTIVE COMPARATOR

Procedure: Implant

Preference DIEP-flap

ACTIVE COMPARATOR

Procedure: DIEP-flap

Preference implant-based

ACTIVE COMPARATOR

Procedure: Implant

Interventions

DIEP-flap PROCEDURE

Breast reconstruction with a deep inferior epigastric perforator flap

Preference DIEP-flap; Randomised DIEP flap

Implant PROCEDURE

Breast reconstruction with an implant-based technique

Preference implant-based; Randomised implant-based

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (2)

Sahlgrenska university hospital

Gothenburg, 413 45, Sweden

RECRUITING

Sahlgrenska university hospital

Gothenburg, Sweden

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Emma Hansson, PhD

CONTACT

+46313421000; emma.em.hansson@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 8, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)