Trial document




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  DRKS00009630

Trial Description

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Title

Gynecomastia - Differences between the young and old

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Trial Acronym

/

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URL of the Trial

http:///

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Brief Summary in Lay Language

Gynecomastia (greek: gyné = Frauen; mastos = Brust) an enlargement of the male breast and occurs, mostly in its transient form, in 50% of all male adolescents; however occuring in all age groups. The development of gynecomastia is due to the formation of glandular, fibrous and lipomatous tissue. Especially in adolescent males, it is associated with an increased risc of psychological disorders such as depression, anxiety, and social phobia.
The aim of our study was to analyse differences of different gynecomastia types as well as the histological activity grade / ductal proliferation in young and old patient Groups using histopathological results, patient files and surgical records. Furthermore, different surgical techniques as well as their complication and residual/recurrence rates are analysed. Moreover, the clinical outcome and patient satisfaction is examined using a CSQ9-questionnaire at follow-up appointments in which a Palpation of the breast, a short patient interview and a photo documentation is carried out (10-21 years post-op).

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Brief Summary in Scientific Language

Gynecomastia (greek: gyné = Frauen; mastos = Brust) an enlargement of the male breast and occurs, mostly in its transient form, in 50% of all male adolescents; however occuring in all age groups. The development of gynecomastia is due to the formation of glandular, fibrous and lipomatous tissue. Especially in adolescent males, it is associated with an increased risc of psychological disorders such as depression, anxiety, and social phobia.

To date, especially different surgical techniques as well as their residual/recurrence and complication rates are described.

The aim of our study was to analyse differences of different gynecomastia types as well as the histological activity grade / ductal proliferation in young and old patient groups. Furthermore, different surgical techniques as well as their complication and residual/recurrence rates are analysed. Moreover, the clinical outcome and patient satisfaction is examined using a CSQ9-questionnaire at follow-up appointments (10-21 years post-op).
All patients with gynecomastia treated in our department from 1997 – 2015are included in our study. 4 groups are examined: Group 1: 13 – 17 years, Group 2: 18 – 30 years, Group 3: 31 – 49 years, Group 4: 50 – 83 years. The analysis is carried out using surgery descriptions, medical letters and histological exams.

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Organizational Data

  •   DRKS00009630
  •   2015/12/17
  •   [---]*
  •   yes
  •   Approved
  •   451/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N62 -  Hypertrophy of breast
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Interventions/Observational Groups

  •   Analysis of differences of different gynecomastia types as well as the histological activity grade / ductal proliferation in young and old patient groups using histopathological results, patient files and surgical records
  •   Analysis of different surgical techniques as well as their complication and residual/recurrence rates
  •   Analysis of clinical outcome and patient satisfaction using a CSQ9-questionnaire at follow-up appointments in which a palpation of the breast, a short patient interview and a photo documentation is carried out (10-21 years post-op).
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

Comparison of different types of gynecomastia (lipomatous vs. glandular) and the histological activity as well as surgical treatment incl. complication rates in different age groups of patients with gynecomastia analyzing histopatholgical results, patient files and surgical records

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Secondary Outcome

Analysis of outcome and patient satisfaction using clinical examinations and CSQ-9 questionnaires after a follow-up time of 10-21 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/12/21
  •   305
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   13   Years
  •   83   Years
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Additional Inclusion Criteria

Patients with gynecomastia

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Exclusion Criteria

Patients with other breast disorders (benign and malign tumors)

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Addresses

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    • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Plastische und Handchirurgie
    • Ms.  Dr.  Alba  Fricke 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Plastische und Handchirurgie
    • Ms.  Dr.  Alba  Fricke 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Plastische und Handchirurgie
    • Ms.  Dr.  Alba  Fricke 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Plastische und Handchirurgie
    • Ms.  Dr.  Alba  Fricke 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/07/20
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.