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

July 4, 2025 updated by: Vastra Gotaland Region

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 years
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.
10 years
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.
10 years
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.
10 years
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
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications after breast reconstruction
Time Frame: 2 years
Measured in patients randomized to TDAP or latissimus dorsi flap.
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Validation of Breast Q: The Back Appearance scale for Swedish
Time Frame: 1 year
Translation and validation of the instrument for Swedish
1 year
Validation of Breast-Q: The back and shoulder function scale for Swedish
Time Frame: 1 year
Translation and validation of the instrument for Swedish
1 year
Normal material for Breast-Q
Time Frame: 5 years
Measurement of quality of life according to breast-Q in a normative population
5 years
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 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 254-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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