- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07010224
- Original Trial
Elastofibroma Dorsi: Clinical Features, Surgical Outcomes, and Risk Factors
July 23, 2026 updated by: Caner İşevi, MD, Ondokuz Mayıs University
Clinical Characteristics of Elastofibroma Dorsi, Long-Term Outcomes After Surgical Resection, and Analysis of Risk Factors
This study aims to retrospectively evaluate patients who underwent surgical treatment for elastofibroma dorsi, a rare benign tumor typically located in the subscapular region of the chest wall.
The study will analyze demographic and clinical features, risk factors, diagnostic imaging methods, postoperative complications, and recurrence rates.
By identifying potential predictors of complications and recurrence, the study hopes to contribute to the understanding and management of this silent and often incidental lesion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
102
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population consists of adult patients (aged 18 and older) who were diagnosed with elastofibroma dorsi and underwent surgical resection at a single tertiary care center between 2010 and 2025.
All included patients had histopathologically confirmed diagnoses and at least one month of postoperative follow-up available in hospital records.
Description
Inclusion Criteria:
- Patients who underwent surgical treatment for elastofibroma dorsi
- Histopathological confirmation of the diagnosis
- Minimum of 1-month postoperative follow-up available
- Age 18 years or older
- Accessible medical and imaging records in hospital archives
- Signed informed consent available in patient records (if applicable)
Exclusion Criteria:
- Patients diagnosed with elastofibroma dorsi but not treated surgically
- Cases without histopathological confirmation
- Incomplete or insufficient medical and radiological records
- Postoperative follow-up period less than 1 month
- Patients younger than 18 years
- Absence of documented informed consent (if applicable)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Surgically Treated Elastofibroma Dorsi Patients
This cohort includes patients diagnosed with elastofibroma dorsi who underwent surgical resection between 2010 and 2025.
Patients were retrospectively evaluated for demographic characteristics, clinical features, diagnostic methods, surgical findings, postoperative complications, and recurrence during follow-up.
|
Review of archived medical, surgical, and radiological records of patients diagnosed with elastofibroma dorsi and treated surgically.
No active intervention was administered as part of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of Retrospective Data Collection Form
Time Frame: Within 3 months after data collection begins
|
Completion of data collection from medical records of patients diagnosed with elastofibroma dorsi who underwent surgical treatment, including demographic features, clinical presentation, imaging modalities, surgical outcomes, postoperative complications, and recurrence.
|
Within 3 months after data collection begins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nishio J, Isayama T, Iwasaki H, Naito M. Elastofibroma dorsi: diagnostic and therapeutic algorithm. J Shoulder Elbow Surg. 2012 Jan;21(1):77-81. doi: 10.1016/j.jse.2011.01.043. Epub 2011 Apr 27.
- Isevi C, Celik B, Pirzirenli MG, Omur F, Elverdi HF, Buyukkarabacak Y. Elastofibroma dorsi: determinants of symptom burden, bilaterality, and perioperative morbidity in 102 surgically treated patients. BMC Surg. 2026 Apr 27;26(1):405. doi: 10.1186/s12893-026-03770-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
May 30, 2025
First Submitted That Met QC Criteria
June 6, 2025
First Posted (Actual)
June 8, 2025
Study Record Updates
Last Update Posted (Actual)
July 24, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- B.30.2.ODM.0.20.08/280
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.