Breast Cancer Clinical Trial
Official title:
Secondary Breast Reconstruction in Irradiated Patients - Prospective Trial Comparing DIEP to Brava Expansion + Fat Transplantation
NCT number | NCT04273464 |
Other study ID # | 1097.13 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | February 2022 |
Verified date | December 2022 |
Source | Sykehuset Telemark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Methods for breast reconstruction after mastectomy vary from rather simple techniques using expanders and implants, local flaps alone or in combination with implants, to more complex methods using autologous tissue.Transverse rectus abdominis muscle (TRAM) flap has since 1983 become golden standard in autologous breast reconstruction. The deep inferior epigastric perforator (DIEP)-flap, the very last improvement of TRAM flap, has been used in breast reconstruction after mastectomy and radiation therapy as the method of choice at the Department for Plastic Surgery at Hospital of Telemark since 2000.Transplantation of fat tissue by lipoinjections is an alternative method for partial breast reconstruction. In recent years, fat transplantation techniques have gained interest even for patients after mastectomy, as donor site morbidity and operative trauma seem to be less than when free flaps are used. Best results are obtained if the skin around mastectomy scar is pretreated with external expansion. The results of breast reconstruction with fat transplantation are promising, but have not been compared to microsurgical reconstruction of the breast in a scientific manner. The present project is designed to address clinical questions regarding efficiency and patient satisfaction of the two methods.
Status | Completed |
Enrollment | 57 |
Est. completion date | February 2022 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Women who have consented to participate in the study and underwent mastectomy and radiation therapy. 2. Mammography of the remaining breast performed within 3 months before surgery 3. At least 1 year after completion of radiotherapy 4. BMI between 22 and 32 - Exclusion Criteria: 1. Patients with recurrent or metastatic breast cancer 2. Patients with pacemakers or metal clips after any surgery 3. Patients with heart, kidney or liver failure or other medical conditions such as severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes 4. Patients with claustrophobia 5. Patients with severe drug abuse 6. Patients with silicone allergy 7. Patients with bleeding disorders 8. Patients who smoke or have smoked in the last two months |
Country | Name | City | State |
---|---|---|---|
Norway | Telemark Hospital | Skien | Telemark |
Lead Sponsor | Collaborator |
---|---|
Sykehuset Telemark |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breast-Q reconstructive module | Patient-related outcome by Breast-Q questionnaire. The Breast-Q™ was developed and provided by the Memorial Sloan Kettering Cancer Center (New York, USA) and the University of British Columbia (Vancouver, British Columbia, Canada). Translation of the BCT Breast-Q™ module into Norwegian was approved in 2014. The questionnaire contains nine domains: satisfaction with breasts, adverse effects of radiation, psychosocial and physical well-being, and different aspects of satisfaction with care. Breast Q preoperative and Breast QQ Breast Q pre- and postoperative scores were registered | Change in Breast Q score from preop. status(baseline) to 3 months postop.score for Brava group and 6 months for DIEP group | |
Primary | Early complications | Complications registered in relation to the surgical sessions | Three months after first two fat grafting sessions in Brava reonstruction group | |
Secondary | Telemark breast score | Using the Telemark braest score for assessment of esthetic result | 3 months after completion of reconstruction for Brava, and 6 months after completion of reconstruction for DIEP-group |
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