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

Completed

• Conditions: Complications, Postoperative/Perioperative; Quality of Life; Satisfaction, Patient
• Interventions: Other: BREAST-Q Questionnaire

• Registration Number: NCT06295042
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2019-10-10
• Primary Completion: 2023-11-28
• Study Completion: 2024-02-01
• Study First Submitted: 2024-02-27
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autologous Breast Reconstruction	BREAST-Q Questionnaire	Patients undergoing autologous breast reconstruction with free flaps
Alloplastic Breast Reconstruction	BREAST-Q Questionnaire	Patients undergoing alloplastic breast reconstruction with implants or expander prosthesis

Primary Outcome Measures

Name	Time	Method
Complications	Retrospective 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 Outcome Measures

Name	Time	Method
Health-related quality of life and satisfaction	Retrospective 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.

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria