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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Latissimus dorsi flap; Procedure: Thoracodorsal artery perforator flap to breast; Procedure: Deep inferior epigastric perforator flap

• Registration Number: NCT04526561
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 550

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast reconstruction latissimus dorsi	Latissimus dorsi flap	Breast reconstruction performed with latissimus dorsi
Breast reconstruction TDAP	Thoracodorsal artery perforator flap to breast	Breast reconstruction performed with TDAP
Breast reconstruction with DIEP	Deep inferior epigastric perforator flap	Breast reconstruction performed with a deep inferior epigastric artery perforator flap

Primary Outcome Measures

Name	Time	Method
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.
Abdominal satisfaction after breast reconstruction	10 years	Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
Complications after breast reconstruction	2 years	Measured in patients randomized to TDAP or latissimus dorsi flap.

Trial Locations

Locations (1)

Sahlgrenska university hospital; 🇸🇪 Gothenburg, Sweden