Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction
GoBreast
GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods
1 other identifier
interventional
220
0 countries
N/A
Brief Summary
A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2008
CompletedFirst Submitted
Initial submission to the registry
May 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJuly 3, 2025
June 1, 2025
12.1 years
May 21, 2019
June 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Aesthetic outcome
Photo evaluations
1 year post-operatively
Secondary Outcomes (8)
Breast related quality of life and satisfaction
Pre-operatively and 3 years post-operatively
General quality of life measurement used for health economics
Pre-operatively and 3 years post-operatively
Depression
Pre-operatively and 3 years post-operatively
General quality of life
Pre-operatively and 3 years post-operatively
Early complication frequency
2 weeks post-operatively
- +3 more secondary outcomes
Study Arms (2)
Irradiated women
OTHERIrradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap.
Non-irradiated women
OTHERNon-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
Interventions
Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
Eligibility Criteria
You may qualify if:
- Age 18-60
- DIEP is technically possible
- Unilateral mastectomy
- BMI\<30
You may not qualify if:
- Scars on abdomen or back
- Bilateral mastectomy
- Previous liposuction abdomen
- years of age or older
- Non-irradiated patients
- \>18 years of age
- Unilateral mastectomy
- BMI\<30
- Bilateral mastectomy
- extensive scars on thorax
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Brorson F, Thorarinsson A, Kolby L, Elander A, Hansson E. Early complications in delayed breast reconstruction: A prospective, randomized study comparing different reconstructive methods in radiated and non-radiated patients. Eur J Surg Oncol. 2020 Dec;46(12):2208-2217. doi: 10.1016/j.ejso.2020.07.010. Epub 2020 Jul 26.
PMID: 32807615RESULTBrorson F, Elander A, Thorarinsson A, Hansson E. Patient Reported Outcome and Quality of Life After Delayed Breast Reconstruction - An RCT Comparing Different Reconstructive Methods in Radiated and Non-radiated Patients. Clin Breast Cancer. 2022 Dec;22(8):753-761. doi: 10.1016/j.clbc.2022.09.004. Epub 2022 Sep 17.
PMID: 36210311RESULTThorarinsson A, Frojd V, Kolby L, Liden M, Elander A, Mark H. Patient determinants as independent risk factors for postoperative complications of breast reconstruction. Gland Surg. 2017 Aug;6(4):355-367. doi: 10.21037/gs.2017.04.04.
PMID: 28861376RESULTThorarinsson A, Frojd V, Kolby L, Ljungdal J, Taft C, Mark H. Long-Term Health-Related Quality of Life after Breast Reconstruction: Comparing 4 Different Methods of Reconstruction. Plast Reconstr Surg Glob Open. 2017 Jun 21;5(6):e1316. doi: 10.1097/GOX.0000000000001316. eCollection 2017 Jun.
PMID: 28740762RESULTThorarinsson A, Frojd V, Kolby L, Modin A, Lewin R, Elander A, Mark H. Blood loss and duration of surgery are independent risk factors for complications after breast reconstruction. J Plast Surg Hand Surg. 2017 Oct;51(5):352-357. doi: 10.1080/2000656X.2016.1272462. Epub 2017 Jan 26.
PMID: 28122466RESULTThorarinsson A, Frojd V, Kolby L, Lewin R, Molinder N, Lundberg J, Elander A, Mark H. A retrospective review of the incidence of various complications in different delayed breast reconstruction methods. J Plast Surg Hand Surg. 2016;50(1):25-34. doi: 10.3109/2000656X.2015.1066683. Epub 2015 Sep 11.
PMID: 26360138RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
May 21, 2019
First Posted
May 24, 2019
Study Start
March 8, 2008
Primary Completion
April 1, 2020
Study Completion
December 1, 2025
Last Updated
July 3, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share