Clinical trial · Interventional
Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction
GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods
NCT03963427CI-TRIAL-00091751GoBreastactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Irradiated women
- description
- Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap.
- interventionNames
- Procedure: Breast reconstruction
- type
- OTHER
- label
- Non-irradiated women
- description
- 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.
- interventionNames
- Procedure: Breast reconstruction
Primary outcomes (1)
- measure
- Aesthetic outcome
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Irradiated patients: Inclusion Criteria: * Age 18-60 * DIEP is technically possible * Unilateral mastectomy * BMI\<30 Exclusion Criteria: * Scars on abdomen or back * Bilateral mastectomy * Previous liposuction abdomen * 61 years of age or older Non-irradiated patients Inclusion Criteria: -\>18 years of age * Unilateral mastectomy * BMI\<30 Exclusion Criteria: * Bilateral mastectomy * extensive scars on thorax
References
Publications (7)
- RESULTBrorson 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 32807615
- RESULTBrorson 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 36210311
- RESULTThorarinsson 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 28861376
- RESULTThorarinsson 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 28740762
- RESULTThorarinsson 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 28122466
- RESULTThorarinsson 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 26360138