Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction

Breast Cancer Female Clinical Trial

— GoBreast  

Official title:

GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03963427
• Other study ID #: Bröst-07:2-4
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 8, 2008
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Surgery--Complications

Intervention

Procedure:
• Breast reconstruction
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aesthetic outcome	Photo evaluations	1 year post-operatively
Secondary	Breast related quality of life and satisfaction	Breast-q. Measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.	Pre-operatively and 3 years post-operatively
Secondary	General quality of life measurement used for health economics	EuroQol-5 domensions-3 levels is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.	Pre-operatively and 3 years post-operatively
Secondary	Depression	Beck Depression Inventory (BDI 21) for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome.	Pre-operatively and 3 years post-operatively
Secondary	General quality of life	Short form health survey (SF-36). The scale ranges from 0 to 100 and a higher score indicates a better quality of life.	Pre-operatively and 3 years post-operatively
Secondary	Early complication frequency	Complications described according to Clavien-Dindo	2 weeks post-operatively
Secondary	Long-term complications	Re-operations and corrections	Five years post-operatively
Secondary	Health economics	Costs of different procedures	Five years post-operatively
Secondary	Implant survival	Analysis of number of implants removed over time	19 years

External Links

•   Research group