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

Vastra Gotaland Region

Status: Active, not recruiting

Conditions: Breast Cancer Female; Surgery--Complications

Treatments: Procedure: Breast reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03963427

Bröst-07:2-4

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Irradiated women

Other group

Description:

Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap.

Treatment:

Procedure: Breast reconstruction

Non-irradiated women

Other group

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.

Treatment:

Procedure: Breast reconstruction