Clinical trial · Observational
Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Reconstruction Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Abdominal-based Autogenous Tissue (AAT)
- description
- 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.
- interventionNames
- Procedure: Breast Reconstruction Surgery
- label
- Tissue Expander-Implants (TE/I)
- description
- 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.
- interventionNames
- Procedure: Breast Reconstruction Surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients 18 years of age or older. 2. Patients undergoing breast reconstruction (immediate or delayed) after mastectomy procedure on one or both breasts. 3. 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: 1. Patients who have had previous breast reconstruction surgery. 2. Patients undergoing other procedures during reconstruction surgery, other than the mastectomy itself in the case of immediate or delayed reconstruction. 3. Patients unable to complete the questionnaires due to language barriers. 4. Geographic inaccessibility or inability to adhere to study protocol requirements.
References
Publications (0)
Data not yet available