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Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction

The Complex Relationship of Complications and Patient-reported Outcome Measures in Autologous Versus Alloplastic Breast Reconstruction.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06295042
Enrollment
162
Registered
2024-03-06
Start date
2019-10-10
Completion date
2024-02-01
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, Postoperative/Perioperative, Quality of Life, Satisfaction, Patient

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.

Interventions

Patient-reported outcome measure

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ComplicationsRetrospective data analysis at the time of study inclusion (up to 10 years postoperative)The five-level modified Clavien-Dindo classification is used to objectively classify postoperative complications. A subgroup analysis will be done for complications requiring revision surgery under general anesthesia and complications not requiring revision surgery under general anesthesia.

Secondary

MeasureTime frameDescription
Health-related quality of life and satisfactionRetrospective data analysis at the time of study inclusion (up to 10 years postoperative)Postoperative changes in health-related quality of life are measured using the BREAST-Q questionnaire (postoperative, reconstructive module), an effective and reliable patient-reported outcome measure in breast reconstruction. Questions in each category can be answered on a scale from 0 to 100, with 100 indicating the highest satisfaction or well-being.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026