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

NCT ID: NCT06295042

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2024-02-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Autologous Breast Reconstruction

Patients undergoing autologous breast reconstruction with free flaps

BREAST-Q Questionnaire

Intervention Type: OTHER

Patient-reported outcome measure

Alloplastic Breast Reconstruction

Patients undergoing alloplastic breast reconstruction with implants or expander prosthesis

BREAST-Q Questionnaire

Intervention Type: OTHER

Patient-reported outcome measure

Interventions

BREAST-Q Questionnaire

Patient-reported outcome measure

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

32-235 ex 19/20

Identifier Type: -

Identifier Source: org_study_id