Trial document





This trial has been registered retrospectively.
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  DRKS00008967

Trial Description

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Title

Morbidity of partial and superficial parotidectomy for benign parotid lesions

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The most common lesions of the parotis gland are benign. The most common tumors are pleomorphic adenomas, followed by warthin tumors. The recommended treatment for these lesions is surgery. Because of the most frequent pleomorphic adenomas, a "superficial parodectomy" is the standard surgical procedure. It is characterized by identification of the facial nerve fan and the exstirpation of the complete lateral parotid tussue with the tumor. This surgery leads to an extended tissue resection, which may lead to larger cosmetic disfugurement and may lead to a higher complication rate.
The approach of a "partial parotidectomy" is characterized by the indentification of the facial nerve only nearby the parotid tumor. Therewith, the tussue resection is minimized.
The aim of this study is to analize the rate of early postoperative and of th elong-term complications in both methods.

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Brief Summary in Scientific Language

The most common lesions of the parotis gland are benign (up to 85%). The most common benign tumors are the pleomorphic adenomas, followed by warthin tumors., then cysts and lymph nodes. The recommended treatment for all these lesions is surgical. Because of the most frequent pleomorphic adenomas and their high recuurence rate on case of incomplete resection, a "superficial parodectomy" is the standard surgical procedure for all benign lesions. the surgery is characterized by identification of the complete facial nerve fan and the exstirpation of the complete lateral parotid tussue with the tumor. This surgery leads to an extended tissue resection, which may lead to larger cosmetic disfugurement and may lead to a higher complication rate.
The approach of a "partial parotidectomy" is characterized by the indentification of the facial nerve only nearby the parotid tumor. Therewith, the tussue resection is minimized.
The aim of this study is to analize the rate of early postoperative and of the long-term complications in both methods.

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Organizational Data

  •   DRKS00008967
  •   2015/07/28
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  •   yes
  •   Approved
  •   13-034, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   D37.0 -  Neoplasm of uncertain or unknown behaviour: Lip, oral cavity and pharynx
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Interventions/Observational Groups

  •   Partial parotidectomy
  •   superficial parotidectomy
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Early postoperative complication rate: Bleeding, Sialocele, Pain, facial nerve paralysis

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Secondary Outcome

Long-term complications (Frey´s Syndrome, Sensation loss, Pain, cosmetic disfigurement)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/07/28
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Benign lesion of the parotid gland
Regular facial nerve function
>18years old
Primary operation

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Exclusion Criteria

Unknown dignity of the parotid lesion
Malign lesions of teh parotid gland
Preoperative facial paralysis
Revision surgery
Tumors of the inner lobe of the parotid gland
Diseases which result in a dysfunction of the peripheral nervious system (neurodegenerative dis,. Diabetes mellitus with polyneuropatia, multiple sclerosis)
Pregnancy

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Addresses

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    • HNO Uniklinik Köln
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • HNO-Uniklinik Köln
    • Ms.  PD Dr. med.  Maria  Grosheva 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • HNO-Uniklinik Köln
    • Ms.  PD Dr. med.  Maria  Grosheva 
    • Kerpenerstr.62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • HNO Uniklinik Köln
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/04/26
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Trial Publications, Results and other Documents

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