Trial document




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  DRKS00000398

Trial Description

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Title

Transgastral Appendectomy

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Trial Acronym

TGA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients which are going to be operated by appendectomy because of an acute or chronic appendicitis can be operated with a new operation using natural orifice, (Natural orifice transendolumenal Surgery = NOTES). The appendix will be removed via the stomach. Possible advantages of the operating procedure are less pain post op, a quicker recovery and a lesser risk for incisional hernia. Transvaginal and transgastral operations are currently in experimental and clinical evaluation. The aim of the study is to prove technical feasibility and safety of a laparoscopic assisted transgastral appendectomy.

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Brief Summary in Scientific Language

The aim of the study is to prove technical feasibility and safety of a laparoscopic assisted transgastral appendectomy with a flexible endoscope.

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Organizational Data

  •   DRKS00000398
  •   2010/04/16
  •   [---]*
  •   yes
  •   Approved
  •   2009-208N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1114-7077 
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Health Condition or Problem studied

  •   K35.9 -  Acute appendicitis, unspecified
  •   K36 -  Other appendicitis
  •   K37 -  Unspecified appendicitis
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Interventions/Observational Groups

  •   Laparoscopic assisted transgastral appendectomy
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Characteristics

  •   Interventional
  •   [---]*
  •   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

Feasibility

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Secondary Outcome

Safety

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/10/03
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

-need for appendectomy
-informed consent
-BMI <30
-ASAi-II

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Exclusion Criteria

Pregnancy
Prior abdominal operations
-Peptic ulcers
-Immunosuppression , HIV
-Cirrhosis of the liver, portal hypertension
-Coagulation disorders
-Suspected tumour
- Sepsis with organ failure
- sonographic or clinical suspision of a perforation
- esophageal stenosis or achalasia

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Addresses

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    • Universitätsmedizin Mannheim Chriurgische Klinik Medizinische Fakultät der Universität Heidelberg
    • Mr.  Prof. Dr. med.  Stefan  Post 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin Mannheim Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg
    • Mr.  Dr. med.  Georg  Kähler 
    • Theodor-Kutzer-Ufer
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin Mannheim Zentrale interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg
    • Ms.  Anja  Schmitt 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Mannheim Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät der Universität Heidelberg
    • Mr.  Dr. med.  Georg  Kähler 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/01
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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.