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NCT Number: NCT03963427

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Female Surgery--Complications

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast reconstruction

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.

Primary outcomes

  1. Aesthetic outcome

    Time frame: 1 year post-operatively

    Photo evaluations

Secondary outcomes

  1. Breast related quality of life and satisfaction

    Time frame: 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.

  2. General quality of life measurement used for health economics

    Time frame: 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.

  3. Depression

    Time frame: 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.

  4. General quality of life

    Time frame: 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.

  5. Early complication frequency

    Time frame: 2 weeks post-operatively

    Complications described according to Clavien-Dindo

  6. Long-term complications

    Time frame: Five years post-operatively

    Re-operations and corrections

  7. Health economics

    Time frame: Five years post-operatively

    Costs of different procedures

  8. Implant survival (Ancillary study)

    Time frame: 19 years

    Analysis of number of implants removed over time (Ethical permit: 2021-06131-02)

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods

Acronym: GoBreast

Important dates

Study start
2008
Primary completion
2020
Study completion
2025
First posted
May 24, 2019
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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