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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06295042
• Other study ID #: 32-235 ex 19/20
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: February 1, 2024
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Quality of Life
• Satisfaction, Patient

Intervention

Other:
• BREAST-Q Questionnaire
Patient-reported outcome measure

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)