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

GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery--Complications; Breast Cancer Female
• Intervention / Treatment: Procedure: Breast reconstruction

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Irradiated women; Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap.	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.
Other: Non-irradiated women; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aesthetic outcome	Photo evaluations	1 year post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Early complication frequency	Complications described according to Clavien-Dindo	2 weeks post-operatively
Long-term complications	Re-operations and corrections	Five years post-operatively
Health economics	Costs of different procedures	Five years post-operatively
Implant survival	Analysis of number of implants removed over time	19 years

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Publications and helpful links

General Publications

• 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.

Helpful Links

• Research group

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2008
• Primary Completion (Actual): April 1, 2020
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: breast reconstruction; plastic surgery; microsurgery
• Other Study ID Numbers: Bröst-07:2-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes