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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Female; Surgery--Complications
• Interventions: Procedure: Breast reconstruction

• Registration Number: NCT03963427
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-08
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Primary Completion: 2020-04-01
• Status Verified: 2023-08
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irradiated women	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	Breast reconstruction	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.

Primary Outcome Measures

Name	Time	Method
Aesthetic outcome	1 year post-operatively	Photo evaluations

Secondary Outcome Measures

Name	Time	Method
Breast related quality of life and satisfaction	Pre-operatively and 3 years post-operatively	Breast-q. Measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.
Depression	Pre-operatively and 3 years post-operatively	Beck Depression Inventory (BDI 21) for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome.
General quality of life	Pre-operatively and 3 years post-operatively	Short form health survey (SF-36). The scale ranges from 0 to 100 and a higher score indicates a better quality of life.
General quality of life measurement used for health economics	Pre-operatively and 3 years post-operatively	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.
Early complication frequency	2 weeks post-operatively	Complications described according to Clavien-Dindo
Long-term complications	Five years post-operatively	Re-operations and corrections
Health economics	Five years post-operatively	Costs of different procedures
Implant survival (Ancillary study)	19 years	Analysis of number of implants removed over time (Ethical permit: 2021-06131-02)