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

Medical University of Graz

Status

Completed

Conditions

Quality of Life

Satisfaction, Patient

Complications, Postoperative/Perioperative

Treatments

Other: BREAST-Q Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT06295042

32-235 ex 19/20

Details and patient eligibility

About

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.

Full 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.

Enrollment

162 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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