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OpenTrials
Completed

NCT Number: NCT04526561

Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales

The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.

1. Validation of scales/instrument for Swedish. 2. Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up. 3. Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction. 4. TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska university hospital

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients eligible for breast reconstruction following mastectomy and radiation
  • Non-smokers or ex-smokers (>6 weeks)
  • BMI < 30

Exclusion criteria

  • Inability to leave informed consent
  • Inability to understand Swedish
  • Previous surgery with scaring on back

Treatment and study plan

Latissimus dorsi flap

Procedure

Breast reconstruction

Other names: LD flap

Thoracodorsal artery perforator flap to breast

Procedure

Breast reconstruction

Other names: TDAP

Deep inferior epigastric perforator flap

Procedure

Breast reconstruction

Other names: DIEP flap

Primary outcomes

  1. Patient satisfaction and breast-related quality of life after breast reconstruction

    Time frame: 10 years

    Breast Q reconstruction.The BREAST-Q has multiple domains, each scored from 0 to 100 (higher scores indicate greater satisfaction or quality of life), there is no overall BREAST-Q score.

  2. Back and shoulder function after breast reconstruction

    Time frame: 10 years

    Breast Q the back and shoulder function scale. The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

  3. Back appearance after breast reconstruction

    Time frame: 10 years

    Breast-Q the back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

  4. Shoulder function after breast reconstruction

    Time frame: 10 years

    Western Ontario Osteoarthritis of the shoulder index (WOOS) provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions.Each question has a possible score from 0-100 giving a total score up to 1900. The highest or most symptomatic score is 1900 and the best or asymptomatic score is 0.

  5. Abdominal satisfaction after breast reconstruction

    Time frame: 10 years

    Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100

Secondary outcomes

  1. Complications after breast reconstruction

    Time frame: 2 years

    Measured in patients randomized to TDAP or latissimus dorsi flap.

Other outcomes

  1. Validation of Breast Q: The Back Appearance scale for Swedish

    Time frame: 1 year

    Translation and validation of the instrument for Swedish

  2. Validation of Breast-Q: The back and shoulder function scale for Swedish

    Time frame: 1 year

    Translation and validation of the instrument for Swedish

  3. Normal material for Breast-Q

    Time frame: 5 years

    Measurement of quality of life according to breast-Q in a normative population

  4. Normal material for Breast-Q back appearance scale

    Time frame: 5 years

    Measurement of quality of life according to breast-Q back appaearance scale in a normative population

  5. Normal material for Breast-Q back and shoulder function scale

    Time frame: 5 years

    Measurement of quality of life according to breast-Q back and shoulder function scale in a normative population

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2020
Registry last updated
Jul 9, 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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