Quality of Life Clinical Trial
Official title:
The Complex Relationship of Complications and Patient-reported Outcome Measures in Autologous Versus Alloplastic Breast Reconstruction.
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |