Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295042
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2024-02-27
Brief Title:
Complications and Long-term Satisfaction in Autologous vs Implant-Based Breast Reconstruction
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
The Complex Relationship of Complications and Patient-reported Outcome Measures in Autologous Versus Alloplastic Breast Reconstruction
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The study is conducted at the Medical University of Graz and has been approved by the responsible ethics committee EK 32-235 ex 1920 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 implanttissue 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
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 implanttissue 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None