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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-08

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Female Surgery--Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irradiated women

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

Group Type OTHER

Breast reconstruction

Intervention Type PROCEDURE

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.

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.

Group Type OTHER

Breast reconstruction

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-60
* DIEP is technically possible
* Unilateral mastectomy
* BMI\<30

-\>18 years of age

* 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

* Bilateral mastectomy
* extensive scars on thorax

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No