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

NCT ID: NCT04526561

Last Updated: 2025-07-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Breast reconstruction TDAP

Breast reconstruction performed with TDAP

Group Type ACTIVE_COMPARATOR

Thoracodorsal artery perforator flap to breast

Intervention Type PROCEDURE

Breast reconstruction

Breast reconstruction latissimus dorsi

Breast reconstruction performed with latissimus dorsi

Group Type ACTIVE_COMPARATOR

Latissimus dorsi flap

Intervention Type PROCEDURE

Breast reconstruction

Breast reconstruction with DIEP

Breast reconstruction performed with a deep inferior epigastric artery perforator flap

Group Type ACTIVE_COMPARATOR

Deep inferior epigastric perforator flap

Intervention Type PROCEDURE

Breast reconstruction

Interventions

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Latissimus dorsi flap

Breast reconstruction

Intervention Type PROCEDURE

Thoracodorsal artery perforator flap to breast

Breast reconstruction

Intervention Type PROCEDURE

Deep inferior epigastric perforator flap

Breast reconstruction

Intervention Type PROCEDURE

Other Intervention Names

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LD flap TDAP DIEP flap

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahlgrenska university hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 34217326 (View on PubMed)

Other Identifiers

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254-18

Identifier Type: -

Identifier Source: org_study_id

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