Breast reconstruction using back muscle flaps and quality of life assessment
Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
This study is testing how well different types of breast reconstruction using back muscle flaps work and how they affect the quality of life for women after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT04526561 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the long-term effects of breast reconstruction using the latissimus dorsi flap, a common technique. It includes a validation of quality of life scales in Swedish, a ten-year retrospective follow-up on latissimus dorsi flap outcomes, and two randomized controlled trials comparing the thoracodorsal artery perforator flap and limber flap for breast reconstruction and axillary hidradenitis suppurativa. The study aims to provide comprehensive data on the effectiveness and quality of life impacts of these reconstruction methods.
Who should consider this trial
Good fit: Ideal candidates are patients eligible for breast reconstruction following mastectomy and radiation, who are non-smokers with a BMI under 30.
Not a fit: Patients who cannot provide informed consent, do not understand Swedish, or have previous scarring on their back may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of breast reconstruction outcomes and improve quality of life for patients undergoing these procedures.
How similar studies have performed: Other studies have shown success with similar reconstruction techniques, but this study aims to provide new insights and validation specific to the Swedish population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gothenburg
- Sahlgrenska university hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Emma Hansson, PhD, MD
- Email: emma.hansson.2@gu.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.