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.

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Satisfaction, Patient; Complications, Postoperative/Perioperative
• Intervention / Treatment: Other: BREAST-Q Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Autologous Breast Reconstruction; Patients undergoing autologous breast reconstruction with free flaps	Other: BREAST-Q Questionnaire; Patient-reported outcome measure
Alloplastic Breast Reconstruction; Patients undergoing alloplastic breast reconstruction with implants or expander prosthesis	Other: BREAST-Q Questionnaire; Patient-reported outcome measure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	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.	Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life and satisfaction	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.	Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): November 28, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 32-235 ex 19/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No