Clinical trial NCT03963427: Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction
Official title: GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Surgery--Complications
Keywords: breast reconstruction
plastic surgery
microsurgery
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2019-05-24
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Aesthetic outcome
timeFrame: 1 year post-operatively
Secondary outcomes:
measure: Breast related quality of life and satisfaction
timeFrame: Pre-operatively and 3 years post-operatively
measure: General quality of life measurement used for health economics
timeFrame: Pre-operatively and 3 years post-operatively
measure: Depression
timeFrame: Pre-operatively and 3 years post-operatively
measure: General quality of life
timeFrame: Pre-operatively and 3 years post-operatively
measure: Early complication frequency
timeFrame: 2 weeks post-operatively
measure: Long-term complications
timeFrame: Five years post-operatively
measure: Health economics
timeFrame: Five years post-operatively
measure: Implant survival (Ancillary study)
timeFrame: 19 years
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Brorson 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.
citation: Thorarinsson 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.
citation: Thorarinsson 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.
citation: Thorarinsson 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.
citation: Thorarinsson 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.