Trial document





This trial has been registered retrospectively.
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  DRKS00017413

Trial Description

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Title

Factors affecting outcomes after supermicrosurgical lymphovenous anastomosis in a defined patient population

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background:
By the creation of lymphovenous anastomoses, local improvements can be achieved in patients with conservatively therapy-resistant lymphedema, especially in the area of the applied shunts between a suitable lymph vessel and vein. However, there are still no generally valid recommendations for the ideal postoperative treatment of patients after lymphovenous anastomoses.

Objective:
By the analysis of all relevant pre-, intra- and postoperative factors in patients with lymphovenous anastomoses, the most important influencing factors for a better outcome shall be determined. From these results it will also be worked out how the current intra- and postoperative treatment options and thus the prognosis can be improved after lymphovenous anastomoses.

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Brief Summary in Scientific Language

This study aims to determine the short- and long-term results as well as the most important factors that can improve outcomes after minimally invasive supermicrosurgical lymphovenous anastomosis (LVA).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017413
  •   2019/06/25
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  •   yes
  •   Approved
  •   10/10/14, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   I89.0 -  Lymphoedema, not elsewhere classified
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Interventions/Observational Groups

  •   Patients who received lymphovenous anastomoses for an existing therapy-resistant lymphedema after exhausting conservative therapy measures.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of this study is to determine the short- and long-term results as well as the most important factors after lymphovenous anastomosis by analyzing all relevant pre-, intra- and postoperative factors in a defined patient population until the end of follow-up on 15.09.2018.
Other primary endpoints was a surgical revision or death.

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Secondary Outcome

Extreme worsening of symptoms and increase in lymphedema

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/02/25
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

All adult patients who are able and willing to consent and who have received lymphovenous anastomoses for an existing lymphedema after exhaustion of the conservative therapy measures.

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Exclusion Criteria

Patients with liver dysfunction, known allergy to indocyanine green, sodium iodide, iodine, hyperthyroidism, focal and diffuse thyroid autonomy, pregnancy and lactation.

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Addresses

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Klinik für Unfallchirurgie, Orthopädie und Plastische Chirurgie Universitätsmedizin Göttingen Georg-August-Universität
    • Mr.  Dr.  Eric  Klingelhöfer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • Klinik für Unfallchirurgie, Orthopädie und Plastische Chirurgie Universitätsmedizin Göttingen Georg-August-Universität
    • Mr.  Dr.  Eric  Klingelhöfer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Unfallchirurgie, Orthopädie und Plastische ChirurgieUniversitätsmedizin GöttingenGeorg-August-Universität
    • Mr.  Dr.  Eric  Klingelhöfer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/09/15
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Trial Publications, Results and other Documents

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