Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06295042 |
Other study ID # |
32-235 ex 19/20 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 10, 2019 |
Est. completion date |
February 1, 2024 |
Study information
Verified date |
March 2024 |
Source |
Medical University of Graz |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Current literature on complications and health-related quality of life in autologous and
alloplastic breast reconstruction is inconclusive. Despite the great demand for more
in-depth, long-term studies of both techniques, current evidence is low or moderate and there
are only few studies focusing on both health-related quality of life and complication rates
in the same patient collective.
This study aims at investigating the complex relationship between the occurrence of
complications and patient-reported long-time satisfaction in autologous and alloplastic
breast reconstruction.
Description:
The study is conducted at the Medical University of Graz and has been approved by the
responsible ethics' committee (EK: 32-235 ex 19/20). The study includes female breast cancer
patients who underwent elective breast reconstruction at one of the participating departments
between April 2020 and April 2023. Written informed consent was obtained from all individual
study participants enrolled.
Exclusion criteria is defined as:
- Missing or insufficient information
- combination of reconstruction techniques on the same breast
- reconstruction procedures with insufficient number of cases
- inability to fully understand study procedures and to provide informed consent
Data were first collected retrospectively from the clinical data management programs using
surgical reports, outpatient charts, and physicians' letters. Personal data such as patient
age, concomitant diseases, nicotine abuse, anticoagulation status, previous oncological
therapy and surgery, etc. were acquired. Furthermore, surgery-related data (site and type of
reconstruction, size and location of implant/tissue expander, intraoperative complications)
and data on the postoperative course (early and late complications, revision surgeries,
number of total surgeries required, etc.) were acquired.
The five-level modified Clavien-Dindo classification is used to objectively classify
postoperative complications, to allow further comparisons between treatment options,
different time periods and correlations to health-related quality of life. Postoperative
changes in health-related quality of life are measured using the BREAST-Q questionnaire, an
effective and reliable patient-reported outcome measure in breast reconstruction.