Clinical trial NCT06295042: Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction
Official title: The Complex Relationship of Complications and Patient-reported Outcome Measures in Autologous Versus Alloplastic Breast Reconstruction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications, Postoperative/Perioperative
Quality of Life
Satisfaction, Patient
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female breast cancer patients between 18 and 80 years who underwent autologous or alloplastic breast reconstruction at our department, willing to participate in this study.

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* female breast cancer patient undergoing autologous or alloplastic breast reconstruction willing to participate in this study
* age between 18 and 80 years (upper limit due to indication for breast reconstruction)
* written informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Complications
timeFrame: Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)
Secondary outcomes:
measure: Health-related quality of life and satisfaction
timeFrame: Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References: