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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04526561
• Other study ID #: 254-18
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Vastra Gotaland Region
• Contact: Emma Hansson, PhD, MD
• Phone: +46313421000
• Email: emma.hansson.2[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Latissimus dorsi flap
Breast reconstruction
• Thoracodorsal artery perforator flap to breast
Breast reconstruction
• Deep inferior epigastric perforator flap
Breast reconstruction

Locations

Country	Name	City	State
Sweden	Sahlgrenska university hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Validation of Breast Q: The Back Appearance scale for Swedish	Translation and validation of the instrument for Swedish	1 year
Other	Validation of Breast-Q: The back and shoulder function scale for Swedish	Translation and validation of the instrument for Swedish	1 year
Other	Normal material for Breast-Q	Measurement of quality of life according to breast-Q in a normative population	5 years
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Complications after breast reconstruction	Measured in patients randomized to TDAP or latissimus dorsi flap.	2 years