Trial document




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  DRKS00003635

Trial Description

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Title

Laparoscopic hysterectomy with 3,5mm instruments

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Trial Acronym

LH 3,5

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Performing a hysterectomy there are different possibilities. If it is done minimal invasive (laparoscopically) it is usually performed with instruments with a 5mm diameter. Pediatric surgeons are using already since years instruments with a diameter of only 3,5 mm. With this trial we will show that a hysterectomy can be performed save with these small instruments.

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Brief Summary in Scientific Language

A laparoscopic hysterectomy is usually performed with 5mm instruments. With this trial we want to proof that 3,5mm instruments can be used with the same outcome for the patients.

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Organizational Data

  •   DRKS00003635
  •   2012/04/04
  •   [---]*
  •   yes
  •   Approved
  •   2012-400M-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1129-2241 
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Health Condition or Problem studied

  •   D25.9 -  Leiomyoma of uterus, unspecified
  •   N92.0 -  Excessive and frequent menstruation with regular cycle
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Interventions/Observational Groups

  •   In 25 patients with the indication for a laparoscopic hysterectomy it will be performed laparoscopically with 3,5mm instruments
  •   Since 2011 we performe laparoscopic hysterectomies with 5mm instruments. These patients are taken as the control group
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Time needed for the operation with the smaller instruments. The time is electronically documented and will be requested after the operation.

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Secondary Outcome

Bloodloss because of the smaller instruments. This will be checked by hemoglobin level within 24 hours after the operation and compared with the level before the operation. The 50 operated patients will be compared to 50 patients already operated with 5mm instruments.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/04/15
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Indication for laparoscopic hysterectomy

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Exclusion Criteria

Patients who refuse to take part in the trial

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Mannheim
    • Mr.  Dr.  Amadeus  Hornemann 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsklinikum Mannheim
    • Mr.  Dr. med.  Amadeus  Hornemann 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsklinikum Mannheim
    • Mr.  Dr. med.  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
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/17
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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.