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

NCT02438449 | Completed

• 1 other identifier: MSA-2015-04
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast reconstruction; mastectomy; health-related quality of life; Health Utilities Index; HUI; prospective; quality-adjusted life years; QALY

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• Healthcare resource utilization including out-of-pocket expenses by patients

  1 year

Study Arms (2)

Abdominal-based Autogenous Tissue (AAT)

The AAT-based breast reconstruction surgery will include any of the following techniques: pedicled transverse rectus abdominis myocutaneous (TRAM) flap, Free TRAM, muscle-sparting TRAM flap, deep inferior epigastric perforator (DIEP) flap, superficial inferior epigastric artery (SIEA) flap, and Rubens flap.

Procedure: Breast Reconstruction Surgery

Tissue Expander-Implants (TE/I)

The TE/I approach will include two-stage breast reconstruction surgery. In the initial stage, immediately after mastectomy and with or without sentinel node biopsy, an expander will be placed in the subpectoral plane and the defect closed. Two weeks after the surgery, the expansion of the TE will commence until the desired volume of the respective expander is achieved. The second stage will include removal of the TE and the placement of a permanent implant which may be either saline or gel. The delayed method will be similar to the immediate reconstruction with the exception of the incision, which will be relatively smaller as the mastectomy was performed previously with breast cavity being fully closed.

Procedure: Breast Reconstruction Surgery

Interventions

Breast Reconstruction Surgery PROCEDURE

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

Abdominal-based Autogenous Tissue (AAT); Tissue Expander-Implants (TE/I)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients undergoing breast reconstruction after mastectomy on one or both breasts being seen by one of the participating plastic surgeons. If patients qualify for the trial according to the inclusion and exclusion criteria, they will be invited to participate in the study and will be required to provide written informed consent.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• McMaster Surgical Associates: collaborator

Study Sites (1)

St. Joseph's Healthcare / McMaster University

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Achilleas Thoma, MD MSc FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Achilleas Thoma

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 8, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: April 1, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

CA (1)