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

Sponsor
Vastra Gotaland Region (Other)
Overall Status
Recruiting
CT.gov ID
NCT04526561
Collaborator
(none)
550
Enrollment
1
Location
3
Arms
65
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Latissimus dorsi flap
  • Procedure: Thoracodorsal artery perforator flap to breast
  • Procedure: Deep inferior epigastric perforator flap
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
550 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Breast reconstruction TDAP

Breast reconstruction performed with TDAP

Procedure: Thoracodorsal artery perforator flap to breast
Breast reconstruction
Other Names:
  • TDAP

    		•
    Active Comparator: Breast reconstruction latissimus dorsi

    Breast reconstruction performed with latissimus dorsi

    Procedure: Latissimus dorsi flap
    Breast reconstruction
    Other Names:
  • LD flap

    		•
    Active Comparator: Breast reconstruction with DIEP

    Breast reconstruction performed with a deep inferior epigastric artery perforator flap

    Procedure: Deep inferior epigastric perforator flap
    Breast reconstruction
    Other Names:
  • DIEP flap

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient satisfaction and breast-related quality of life after breast reconstruction [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 [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 [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 [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 [10 years]

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

    Secondary Outcome Measures

    1. Complications after breast reconstruction [2 years]

      Measured in patients randomized to TDAP or latissimus dorsi flap.

    Other Outcome Measures

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

      Translation and validation of the instrument for Swedish

    2. Validation of Breast-Q: The back and shoulder function scale for Swedish [1 year]

      Translation and validation of the instrument for Swedish

    3. Normal material for Breast-Q [5 years]

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

    4. Normal material for Breast-Q back appearance scale [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 [5 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska university hospital Gothenburg Sweden 413 45

    Sponsors and Collaborators

    • Vastra Gotaland Region

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vastra Gotaland Region
    ClinicalTrials.gov Identifier:
    NCT04526561
    Other Study ID Numbers:
    • 254-18
    First Posted:
    Aug 26, 2020
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 1, 2022