Complications, Postoperative/PerioperativeNCT06295042
Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction
An observational study of Complications, Postoperative/Perioperative and Quality of Life, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications, Postoperative/Perioperative, Quality of Life, Satisfaction, Patient
- What is being tested?
- BREAST-Q Questionnaire
- How many people
- 162 participants
- Where
- 1 siteAustria
- Study dates
- 10 Oct 2019to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- BREAST-Q Questionnaire
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREAST-Q QuestionnaireOther
Patient-reported outcome measure
| Study group | Role | What they receive |
|---|---|---|
| Autologous Breast Reconstruction | Patients undergoing autologous breast reconstruction with free flaps Receives: Other: BREAST-Q Questionnaire | |
| Alloplastic Breast Reconstruction | Patients undergoing alloplastic breast reconstruction with implants or expander prosthesis Receives: Other: BREAST-Q Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)
Secondary outcomes (1)
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.
Measured: Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start10 Oct 2019
- Primary completion28 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications, Postoperative/PerioperativeStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295042
- Sponsor's protocol ID
- 32-235 ex 19/20
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Luze H, Muller-Huck H, Stella C, Hasiba-Pappas S, Hubmer M, Justich I, Winter R, Peintinger F, Kamolz LP, Nischwitz SP. The complex relation of complications and long-term satisfaction in breast reconstruction after mastectomy: A comparative clinical study. J Plast Reconstr Aesthet Surg. 2026 Apr;115:24-32. doi: 10.1016/j.bjps.2026.02.001. Epub 2026 Feb 10.
PubMed 41722472
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Complex Relationship of Complications and Patient-reported Outcome Measures in Autologous Versus Alloplastic Breast Reconstruction.
- ClinicalTrials.gov ID
- NCT06295042
- Acronym / sponsor ID
- 32-235 ex 19/20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Breast Reconstruction | – | Other: BREAST-Q QuestionnairePatients undergoing autologous breast reconstruction with free flaps |
| Alloplastic Breast Reconstruction | – | Other: BREAST-Q QuestionnairePatients undergoing alloplastic breast reconstruction with implants or expander prosthesis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREAST-Q QuestionnairePatient-reported outcome measure | Other | Alloplastic Breast Reconstruction, Autologous Breast Reconstruction |
Primary outcome
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.
1 secondary outcome
Health-related quality of life and satisfaction
Time frame: Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 41722472Luze H, Muller-Huck H, Stella C, Hasiba-Pappas S, Hubmer M, Justich I, Winter R, Peintinger F, Kamolz LP, Nischwitz SP. The complex relation of complications and long-term satisfaction in breast reconstruction after mastectomy: A comparative clinical study. J Plast Reconstr Aesthet Surg. 2026 Apr;115:24-32. doi: 10.1016/j.bjps.2026.02.001. Epub 2026 Feb 10.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications, Postoperative/Perioperative and Quality of Life, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Retrospective data analysis at the time of study inclusion (up to 10 years postoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06295042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.