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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Thoracodorsal artery perforator flap to breast; Procedure: Latissimus dorsi flap; Procedure: Deep inferior epigastric perforator flap

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Hansson, PhD, MD; Phone Number: +46313421000; Email: emma.hansson.2@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Emma Hansson, PhD; Phone Number: +46 31 342 10 00; Email: emma.hansson.2@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications after breast reconstruction	Measured in patients randomized to TDAP or latissimus dorsi flap.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of Breast Q: The Back Appearance scale for Swedish	Translation and validation of the instrument for Swedish	1 year
Validation of Breast-Q: The back and shoulder function scale for Swedish	Translation and validation of the instrument for Swedish	1 year
Normal material for Breast-Q	Measurement of quality of life according to breast-Q in a normative population	5 years
Normal material for Breast-Q back appearance scale	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	Measurement of quality of life according to breast-Q back and shoulder function scale in a normative population	5 years

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID 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