Trial document




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  DRKS00004377

Trial Description

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Title

Comparison of the multiport system with a single port system in patients undergoing SILS-cholezystectomy

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Trial Acronym

Music study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The concept of single incision surgery has become very common over the last years. There are many single-port solutions available with the two main disadvantages of high costs and low flexibility of intsrument handling intraoperatively. This study is designed to compare a new developed multiport-solution with a commercially available single-port solution with regard to duration of operative time, costs, problems with wound-healing, pain postoperative and the incidence of incisional hernia with a one year follow-up.
A pilot study showed a shortening of duration for operative procedure and less postoperative pain when using the newly established multiport-solution. Patients with uncomplicate cholecystolithiasis were enrolled in this study.

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Brief Summary in Scientific Language

The concept of single incision surgery has become very common over the last years. The two main problems of commercially available single-port solutions are high costs and low flexibility of intsrument handling intraoperatively. We established a cheaper multiport-solution with a improved instrument handling intraoperatively.This prospective, randomized study is designed to compare a the developed multiport-solution with a commercially available single-port solution (SILS-Port, Covidien, USA) with regard to duration of operative time, costs, problems with wound-healing, pain postoperative and the incidence of incisional hernia with a one year follow-up.
A pilot study showed a shortening of duration for operative procedure and less postoperative pain when using the newly established multiport-solution. Patients with uncomplicate cholecystolithiasis were enrolled in this study.

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Organizational Data

  •   DRKS00004377
  •   2012/09/14
  •   [---]*
  •   yes
  •   Approved
  •   2012-189-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   K80.20 -  [generalization K80.2: Calculus of gallbladder without cholecystitis]
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Interventions/Observational Groups

  •   SILS-cholezystectomy using the SILS-Port Covidien
  •   SILS-cholezystectomy using three 5 mm ptrocars from Braun/Aesculap
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Characteristics

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

measurement of the duration of operative procedure of arm a and b with comparison

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Secondary Outcome


aditional suture for better exposition or additional trocars intraoperatively;
complications intraoperative and postoperative;
pain score postoperative (VAS) day 1-7;
duration and dosage of drugs against pain;
duration of hospital stay in days;
return to normal activity in days;
length of fascial incision in mm;
incidence of incisional hernia follow up 1 year with clinical examination and ultrasound

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/09/12
  •   42
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

symtomatic cholecystolithiasis, polyp of the gall bladder, BMI< 30

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Exclusion Criteria

acute cholecystitis;
Patient underwent ERCP for choledocholithiasis within the last 30 days;
previous operative intervention of upper GI;
BMI>30;
ASA score 4 -6;
liver cirrhosis;
severe psychiatric diagnosis;
pregnancy and breastfeeding;
anticoagulation for any reason;
umbilical hernia

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Addresses

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    • Klinik für Allgemein-und Visceralchirurgie Klinikum Herford
    • Mr.  Dr. med  Axel  Wittmer 
    • Schwarzenmoorstrasse 70
    • 32049  Herford
    • Germany
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    • Allgemein/Visceralchirurgie Klinikum Herford
    • Mr.  Dr. med  Axel  Wittmer 
    • Schwarzenmoorstrasse 70
    • 32049  Herford
    • Germany
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    • Allgemein/Visceralchirurgie Klinikum Herford
    • Mr.  Dr. med  Axel  Wittmer 
    • Schwarzenmoorstrasse 70
    • 32049  Herford
    • Germany
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Sources of Monetary or Material Support

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    • Allgemein/Visceralchirurgie Klinikum Herford
    • Mr.  Dr. med  Axel  Wittmer 
    • Schwarzenmoorstrasse 70
    • 32049  Herford
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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