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NCT Number: NCT06295042

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

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Key information

Conditions

Complications, Postoperative/Perioperative Behavior Health Behavior Patient Satisfaction Quality of Life Satisfaction, Patient Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Medical University of Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BREAST-Q Questionnaire

Other

Patient-reported outcome measure

Primary outcomes

  1. Complications

    Time frame: 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 outcomes

  1. Health-related quality of life and satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 6, 2024
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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