Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?

NCT04273464 | Completed

• 1 other identifier: 1097.13
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Mammaplasty

Outcome Measures

Primary Outcomes (2)

• 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

• Early complications

  Complications registered in relation to the surgical sessions

  Three months after first two fat grafting sessions in Brava reonstruction group

Secondary Outcomes (1)

• Telemark breast score

  3 months after completion of reconstruction for Brava, and 6 months after completion of reconstruction for DIEP-group

Study Arms (2)

Brava-group

EXPERIMENTAL

External tissue expanders will be used 3 weeks prior to operation and 2 weeks postoperatively in order to enhance the volume and survival of fat cells. We expect that each patient in the fat transplantation group will need 4-6 transplantation sessions of about 1.5 to 2 hours each to achieve satisfactory volume and shape of the breast.31 participants.

Procedure: Brava-group

DIEP-group

ACTIVE COMPARATOR

26 participants. We expect 1-2 operative sessions of respectively 5-7 and 2-3 hours duration in the DIEP group. The risk of reoperation (second operation during the first postoperative week) in the DIEP group is 5-10 %

Procedure: DIEP-group

Interventions

Brava-group PROCEDURE

Breast reconstruction by external tissue expansion and multiple fat transplantations(Brava group); Breast reconstruction with microsurgical DIEP-flap transfer.

Brava-group

DIEP-group PROCEDURE

Microsurgical reconstruction by DIEPO method

DIEP-group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who have consented to participate in the study and underwent mastectomy and radiation therapy.
• Mammography of the remaining breast performed within 3 months before surgery
• At least 1 year after completion of radiotherapy
• BMI between 22 and 32 -

You may not qualify if:

• Patients with recurrent or metastatic breast cancer
• Patients with pacemakers or metal clips after any surgery
• Patients with heart, kidney or liver failure or other medical conditions such as severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes
• Patients with claustrophobia
• Patients with severe drug abuse
• Patients with silicone allergy
• Patients with bleeding disorders
• Patients who smoke or have smoked in the last two months

Sponsors & Collaborators

• Sykehuset Telemark: lead

Study Sites (1)

Telemark Hospital

Skien, Telemark, 3700, Norway

Location

Related Publications (1)

• Begic A, Tolli J, Hegard W, Stark B. Secondary Breast Reconstruction in Irradiated Patients: Prospective Trial Comparing DIEP to Brava Expansion and Fat Transplantation. Plast Reconstr Surg. 2023 Aug 1;152(2):205e-216e. doi: 10.1097/PRS.0000000000010250. Epub 2023 Feb 1.

  PMID: 36723980 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hege Kersten, PhD

  Sykehuset Telemark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective comparative study of two parallell cohorts (BRAVA and DIEP reconstruction methods).

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: February 18, 2020
• Study Start: June 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)