Secondary Breast Reconstruction With a Flap of Skin From the Back

NCT02169011 | Completed DMC

• 1 other identifier: S-20120207
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this study is to examine the different outcomes of breast reconstruction in women who are treated for breast cancer with mastectomy and subsequently have delayed breast reconstruction by one of two different surgical techniques both of which are based on the use of a tissue flap from the patient's back. These techniques are either a latissimus dorsi flap (LD-flap) or a thoracodorsal artery perforator flap (TAP-flap) The main objective of the study is to establish whether one of these techniques may result in a superior outcome and thus should be recommended as first choice treatment rather than the other.

Conditions

Breast Reconstruction

Keywords

Breast reconstruction; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Shoulder Function

  The most important difference between the two procedures is the involvement of the muscle and change in shoulder function is the most relevant clinical measure to investigate. For evaluation of shoulder function we use the internationally validated Constant Shoulder Score (CSS). This system assess pain, function in everyday-life, range of motion and strength and incorporates these parameters into one total score. It is the recommended scoring-system by the European Society of Shoulder and Elbow Surgery. Each variable in the system is evaluated separately. For all patients scoring will be performed preoperatively as well as 3, 6 and 12 months postoperatively. Shoulder function will be evaluated bilaterally at all stages. To avoid multiplicity-issues the primary end-point has been defined as the difference in the total score between the baseline evaluation preoperatively and the evaluation one year postoperatively.

  1 year

Secondary Outcomes (2)

• Patient Reported Discomfort

  1 year

• Rehabilitation

  1 year

Other Outcomes (4)

• Quality-of-life

  1 year

• Socio-economics

  1 year

• Aesthetic Outcome

  1 year

Study Arms (2)

Latissimus Dorsi Flap Reconstruction

ACTIVE COMPARATOR

Patients are allocated to delayed breast reconstruction with the Latissimus Dorsi flap and if needed an implant.

Procedure: Latissimus Dorsi Flap Reconstruction

TAP Flap Reconstruction

ACTIVE COMPARATOR

Patients are allocated to delayed breast reconstruction with the TAP-flap and if needed an implant in combination with an acellular dermal matrix.

Procedure: TAP Flap Reconstruction

Interventions

Latissimus Dorsi Flap Reconstruction PROCEDURE

Delayed, unilateral breast reconstruction with the LD-flap. The reconstruction will be performed in a standard fashion as specified in the protocol. Implants should be used when required to gain sufficient volume of the breast.

Latissimus Dorsi Flap Reconstruction

TAP Flap Reconstruction PROCEDURE

Delayed, unilateral breast reconstruction with the TAP-flap. The reconstruction will be performed as specified in the protocol and when implants are required to gain sufficient volume they should be combined with an acellular dermal matrix.

TAP Flap Reconstruction

Eligibility Criteria

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

You may qualify if:

• \) Women over 18 years of age who are referred in the period between 1st of September 2013 and 30st of August 2015 for the purpose of unilateral, delayed breast reconstruction, and who are found best suited for reconstruction with a pedicled tissue flap from the back.

You may not qualify if:

• Patients found better suited for reconstruction by another method i.e. abdominal or free flap-reconstruction or expander/implant-based reconstruction.
• Patients with severe dementia that makes it impossible to collect data or obtain informed consent
• Non-Danish speaking patients from whom informed consent cannot be obtained by interpreter
• Patients where a suited perforator of the Thoracodorsal artery cannot be identified by colour Doppler ultrasonography.
• Invited patients will receive both oral and written participant information after which a period of minimum 14 days is required before the patient can be enrolled in the trial in accordance with the The Danish Health Act.
• Patients considering participation will be invited for a second consultation where written informed consent will be obtained from all who accept the invitation. Randomization will be performed immediately afterwards allocating the patient to reconstruction by either the LD-flap or the TAP-flap. Patients who do not which to be enrolled in the trial will be offered reconstruction with the LD-flap as this must be considered standard of care.

Sponsors & Collaborators

• Vejle Hospital: lead
• University of Southern Denmark: collaborator
• Region of Southern Denmark: collaborator
• Sygehus Lillebaelt: collaborator

Study Sites (4)

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Telemark Hospital

Skien, Telemark, 3710, Norway

Location

Related Publications (30)

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• Makki A, Thomsen JB, Gunnarsson GL, Holmich PLR, Sorensen PJA, Rindom MB. A cost-effectiveness analysis of delayed breast reconstruction with pedicled flaps from the back. J Plast Reconstr Aesthet Surg. 2022 Jul;75(7):2211-2218. doi: 10.1016/j.bjps.2022.02.034. Epub 2022 Feb 26.

  PMID: 35365412 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jørn B Thomsen, MD, PhD

  Center Hospital Lillebaelt, Institute of Regional Health Research, University of Southern Denmark

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: September 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 31, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

NO (1); DK (3)