Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003271

Trial Description

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Title

Suprapubic cholecystectomy ( in Minden modification) versus standard laparoscopic cholecystectomy, comparison of operating time (OT).

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We carried out the study to verify if the the time required for the suprapubic cholecystectomy in Minden modification (operation B) was similar to the OT required for the standard laparoscopic cholecsytectomy.
The main difference between the two methods is the localization of the instruments used for surgery. When performing the Minden modification, we insert the instruments via a 0,5cm incision in the umbilicus and a second instrument is introduced through an incision (1,5cm) in the pubic area. An auxillary instrument (2- 5mm) may be introduced in the right middle abdomen if prefered. The scars resulting after surgery are barely visible due to their placement.
In the standard cholecystectomy, the instruments are introduced via incisions in upper- or middle abdominal area thus resulting in visible scars.

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Brief Summary in Scientific Language

Objective: To compare operative times between a combined suprapubic-transumbilical laparoscopic cholecystektomy in Minden technique ( MI-CHE) and standard laparoscopic cholecystektomy ( ST-CHE)
Summary background data: MI-CHE is a recently described laparoscopic cholecystektomy technique with barely visible scars. A long 10 mm 45°optic and a long curved grasper are inserted via a suprapubic singel incision. The dissection instrument is introduced trough an intraumbilical 5 mm trocar, optionally an auxillary 3 mm grasper may be punctered into the right abdomen without a trocar. ST-CHE is the standard four trocar cholecystektomy method.
Method: 40 patients with a biliary colic due to bile-stones were operated with the MI-CHE or ST-CE (20 per group) in a prospective randomised study. The surgery will be performed by 4 surgeons who have never done a laparoscopic cholecystectomy before. All surgeons will be assisted by the same responsible surgeon who is already familiar with both methods.

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Organizational Data

  •   DRKS00003271
  •   2011/10/14
  •   [---]*
  •   yes
  •   Approved
  •   2009-251f-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

  •   Cholecystectomy in Minden modification with barely visible scars. A long 10 mm 45°optic and a long curved grasper are inserted via a suprapubic singel incision. The dissection instrument is introduced trough an intraumbilical 5 mm trocar, optionally an auxillary 3 mm grasper may be punctered into the right abdomen without a trocar.
  •   standard 4-trocar cholecystektomy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

Comparison of the OT required during the combined suprapubic- transumbilical cholesytectomy in Minden modification (Mi- CHE) and the standard laparoscopic cholesytectomy (ST- CHE). In a prospectiv randomized study, 40 patients with biliary colics due to biliary lithiasis were operated either in the MI-CHE or in the ST- CHE technique (20 in each group). The hypothesis of this study was:
MI-CHE does not require more than 20 min longer than the ST-CHE (XXXX). To aquire the OT required, we refered to the documentation in KIS and documented the data in the self- developed forms " Perioperative Daten und Endpunkt"

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/04/16
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

uncomplicated symptomatic cholecystolithiasis

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Exclusion Criteria

- age < 18 years or not mature

- acute cholecystitis, Mirizzi-syndrom, contracted gallbladder, not refurbished choledocholithiasis, gallstone ileus, perforated cholecystitis, gallbladder carcinoma, “porcelain gallbladder”?, pancreatitis
acute or in anamnesis in each case

- known or expected severe intraabdominal adhesions for example after major intraabdominal operations or after severe peritonitis

- synchron surgeries necessary

- kardiopulmonary contraindications for a laparoscopy surgery

- BMI > 30

- Patient is not willing to participate at the study including the following examinations

- Pregnant woman

- The surgeon already has done a laparoscopy cholecystectomy before the study and the assistant has not done at least 5 interventions of the OP-method A and B

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Johannes Wesling Klinikum Minden Klinik für Allgemein- Viszeral-Thorax-und Gefäßchirurgie
    • Mr.  Prof. Dr. med.  Berthold  Gerdes 
    • Hans-Nolte-Str. 1
    • 32429  Minden
    • Germany
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    • Johannes Wesling Klinikum Minden Klinik für Allgemein- Viszeral-Thorax-und Gefäßchirurgie
    • Mr.  Prof. Dr. med.  Berthold  Gerdes 
    • Hans-Nolte-Str. 1
    • 32429  Minden
    • Germany
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    • Johannes Wesling Klinikum Minden Klinik für Allgemein-Viszeral-Thorax-und Gefäßchirurgie
    • Mr.  Jerzy  Laniewski 
    • Hans-Nolte Str. 1
    • 32429  Minden
    • Germany
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Sources of Monetary or Material Support

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    • Johanes Wesling Klinikum Minden, Klinik für Allgemein-Visceral-Thorax-und Gefäßchirurgie
    • Hans-Nolte-Str. 1
    • 32429  Minden
    • 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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* This entry means the parameter is not applicable or has not been set.