Trial document




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  DRKS00004328

Trial Description

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Title

Prospectiv randomized study about laparoscopic supracervical hysterectomy with and without assistance

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Trial Acronym

LASH S

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A minimal invasive (laparoscopic) hysterectomy without removing the cervix (LASH) is normally performed by a doctor and an additional assistant.
This trial is for patients with indication for a laparoscopic supracervical hysterectomy. In every operation the camera is hold by a roboter and therefore no assistant needed. We want to show
1.) that this operation can be done without an assistant and
2.) will compare it randomly with a control group with assistant for operation time, bloodloss and complications.

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Brief Summary in Scientific Language

A laparoscopic supracervical hysterectomy is usually done by a medical doctor and an assistant. In this trial we will show that the Aesculap roboter can replace the assistant and that the outcome is equal or even better.

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Organizational Data

  •   DRKS00004328
  •   2012/08/22
  •   [---]*
  •   yes
  •   Approved
  •   2012-285N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1133-6739 
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Health Condition or Problem studied

  •   D25.9 -  Leiomyoma of uterus, unspecified
  •   N94.6 -  Dysmenorrhoea, unspecified
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Interventions/Observational Groups

  •   Perfoming a laparoscopic supracervical hysterectomy with the Einstein Vision System (Aesculap) without an additional assistant
  •   Perfoming a laparoscopic supracervical hysterectomy with the Einstein Vision System (Aesculap) with an additional assistant
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

A LASH can be done without the help of an assistant. Parameter: Single surgeon without an assistant (solo surgery)

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Secondary Outcome

Comparing LASH without assistant and LASH with an additional assistant for bloodloss, operation time, complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/08/21
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

There have to be an indication for a LASH

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Exclusion Criteria

No indication for operation

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Addresses

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    • Universitätsklinikum Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsklinikum Mannheim
    • Mr.  Dr. med., MPH  Amadeus  Hornemann 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsklinikum Mannheim
    • Mr.  Dr. med., MPH  Amadeus  Hornemann 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Mannheim
    • Mr.  Prof. Dr. med.  Marc  Sütterlin 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.