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

N/AActive Not RecruitingNCT03963427

Vastra Gotaland Region220 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Breast Cancer Female Surgery--Complications

Interventions

Breast reconstructionPROCEDURE

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

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Aesthetic outcome

Photo evaluations

Time frame: 1 year post-operatively

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Pre-operatively and 3 years post-operatively

Early complication frequency

Complications described according to Clavien-Dindo

Time frame: 2 weeks post-operatively

Long-term complications

Re-operations and corrections

Time frame: Five years post-operatively

Data from ClinicalTrials.gov

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