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

NCT06295042 | Completed

• 1 other identifier: 32-235 ex 19/20
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Health-related quality of life and satisfaction

  Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)

Study Arms (2)

Autologous Breast Reconstruction

Patients undergoing autologous breast reconstruction with free flaps

Other: BREAST-Q Questionnaire

Alloplastic Breast Reconstruction

Patients undergoing alloplastic breast reconstruction with implants or expander prosthesis

Other: BREAST-Q Questionnaire

Interventions

BREAST-Q Questionnaire OTHER

Patient-reported outcome measure

Alloplastic Breast Reconstruction; Autologous Breast Reconstruction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 6, 2024
• Study Start: October 10, 2019
• Primary Completion: November 28, 2023
• Study Completion: February 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• 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

Locations

AU (1)