NCT04526561

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

4.4 years

First QC Date

August 12, 2020

Last Update Submit

July 4, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

  • Patient satisfaction and breast-related quality of life after breast reconstruction

    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.

    10 years

  • Back and shoulder function after breast reconstruction

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

    10 years

  • Back appearance after breast reconstruction

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

    10 years

  • Shoulder function after breast reconstruction

    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.

    10 years

  • Abdominal satisfaction after breast reconstruction

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

    10 years

Secondary Outcomes (1)

  • Complications after breast reconstruction

    2 years

Other Outcomes (5)

  • Validation of Breast Q: The Back Appearance scale for Swedish

    1 year

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

    1 year

  • Normal material for Breast-Q

    5 years

  • +2 more other outcomes

Study Arms (3)

Breast reconstruction TDAP

ACTIVE COMPARATOR

Breast reconstruction performed with TDAP

Procedure: Thoracodorsal artery perforator flap to breast

Breast reconstruction latissimus dorsi

ACTIVE COMPARATOR

Breast reconstruction performed with latissimus dorsi

Procedure: Latissimus dorsi flap

Breast reconstruction with DIEP

ACTIVE COMPARATOR

Breast reconstruction performed with a deep inferior epigastric artery perforator flap

Procedure: Deep inferior epigastric perforator flap

Interventions

Latissimus dorsi flapPROCEDURE

Breast reconstruction

Also known as: LD flap
Breast reconstruction latissimus dorsi
Thoracodorsal artery perforator flap to breastPROCEDURE

Breast reconstruction

Also known as: TDAP
Breast reconstruction TDAP
Deep inferior epigastric perforator flapPROCEDURE

Breast reconstruction

Also known as: DIEP flap
Breast reconstruction with DIEP

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological women identifying themselves as cis-women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska university hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

  • Kamya L, Hansson E, Weick L, Hansson E. Validation and reliability testing of the Breast-Q latissimus dorsi questionnaire: cross-cultural adaptation and psychometric properties in a Swedish population. Health Qual Life Outcomes. 2021 Jul 3;19(1):174. doi: 10.1186/s12955-021-01812-x.

    PMID: 34217326RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 26, 2020

Study Start

August 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 9, 2025

Record last verified: 2025-06

Locations

SE(1)