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Completed

NCT Number: NCT02438449

Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study

It is estimated that about 25% and 40% of health care expenditures in Canada and USA respectively are wasted because of inefficiencies and not practicing evidence-based medicine. As health care resources are scarce it behooves all of us to use these in a cost-effective manner. The term "cost-effective" is used in the health care literature often but erroneously. Investigators compare a "novel' intervention to a "prevailing" one and if the novel intervention is less costly it is labeled "cost-effective". In a methodologically correct cost-effectiveness study however, investigators need to integrate both the effectiveness and costs of the competing interventions and calculate an incremental cost-effective ratio. If this ratio falls within acceptability thresholds, the novel intervention is labeled cost-effective. There are many techniques of breast reconstruction. The two most common approaches are the Autologous Abdominal Tissue (AAT) and the Tissue Expansion / Implant reconstructions. In this study these two most common breast reconstruction approaches after mastectomy due to cancer performed in the Hamilton/Niagara/Haldimand/Brant and Waterloo/Wellington LHINs will be investigated with a cost-effectiveness analysis coupled with a methodologically robust observational study.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

St. Joseph's Healthcare / McMaster University

Hamilton, Ontario, L8N 4A6, Canada

About this study

As a result of the recent advances in the treatment of breast cancer carried out by dedicated researchers and made possible through breast cancer research, its mortality has been gradually declining. Naturally, the quality of survivorship has taken an important role in the last 3 decades. Unfortunately, for most women with breast cancer, their concerns about survival are followed closely with concerns about body image, sexuality, self-esteem and social life. Mastectomy, a mainstay in the treatment of breast cancer, is the primary cause of these latter concerns. The investigators are therefore charged with looking at the disease and the respective treatment of breast cancer holistically. Providing a comprehensive management of breast cancer today requires attention to both oncologic principles and to the patient's quality of life. A large part of the patient's quality of life comes from improved reconstructive and aesthetic outcomes following mastectomy. In short, breast reconstruction after mastectomy for cancer aims to improve body image and quality of life by reducing the negative psychological impact of the deformity. Multiple techniques exist to accomplish this goal. They include breast implants, autologous tissues, or occasionally, a combination thereof. Although the ultimate goal is to recreate an aesthetically pleasing breast that attempts to match the missing one, the decision to use a particular technique is multi-factorial. It may be influenced by the surgeon's skills, the patient's preferences, inherent contraindications with a patient, or the resources available in a particular setting. Breast reconstructions can be costly to patients (indirect costs), third party payers and society, especially as new technologies are introduced in clinical practice. In the last 2 decades third party payers and governments in different jurisdictions have been advocating for production of evidence that shows "value for money" germane to these different procedures.Presently, the two most common approaches to breast reconstruction are the AAT method and the TE/I method. These two approaches to breast reconstruction have yet to be submitted to an economic evaluation using state-of-the-art cost-effectiveness analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older.
  • Patients undergoing breast reconstruction (immediate or delayed) after mastectomy procedure on one or both breasts.
  • Eligible for two step tissue expander and implant based procedure, or one of the following autogenous abdomen tissue-based procedures (pedicled TRAM flap, Free TRAM, ms TRAM flap, DIEP flap, SIEA flap, Rubens flap).

Exclusion criteria

  • Patients who have had previous breast reconstruction surgery.
  • Patients undergoing other procedures during reconstruction surgery, other than the mastectomy itself in the case of immediate or delayed reconstruction.
  • Patients unable to complete the questionnaires due to language barriers.
  • Geographic inaccessibility or inability to adhere to study protocol requirements.

Treatment and study plan

Breast reconstruction surgery

Procedure

AAT-based orTE/I reconstruction in all patients undergoing breast reconstruction following mastectomy

Primary outcomes

  1. Health-related Quality of Life (utilities and disease-specific)

    Time frame: 1 year

Secondary outcomes

  1. Healthcare resource utilization including out-of-pocket expenses by patients

    Time frame: 1 year

    Identify and tabulate the costs for the two procedures under the purview of the patient, Ministry of Health and society. Costs will be further classified into two categories: surgery-related costs and costs incurred by the patient.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • McMaster Surgical Associates

Registry information

Official study title

A Cost-Effectiveness Analysis Comparing Abdominal-based Autogenous Tissue (AAT) and Tissue Expander- Implant (TE/I) Reconstruction of the Breast After Mastectomy- A Feasibility Study

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
May 8, 2015
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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