Trial document




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  DRKS00000302

Trial Description

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Title

Conventional laparoscopic versus needleskopic versus single-port cholecystectomy - a randomised clinical trial

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Trial Acronym

SILS-Che

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Laparoscopic surgery (key-hole surgery) represent the current standard for cholecystectomy. This study examines whether a further reduction of surgical access trauma is useful and helps to prevent postoperative pain.

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Brief Summary in Scientific Language

Trial participants will be randomised in a 1:1:1 ratio into three equally sized treatment groups. Group A (conventional cholecystectomy): Beside the 10mm optic trocar in the bellybutton, 3 further trocars are inserted, two 5 mm trocars in the right upper abdomen, and one 10 mm trocar in the left abdomen. Group B (needlescopic cholecystectomy): The three working trocars all have a diameter of only 3 mm. Gruppe C (SILS): The Single Port System (SILS? by Covidien) is placed in the bellybutton.
The trial is patient-blinded, in order to obtain unbiased subjective endpoint measurements during the postoperative in-hospital stay. Blinding is achieved by the use of similar wound dressings in the three groups. The primary endpoint of the trial is the intensity of pain during movement as measured on postoperative day 1 to 3. This includes a total of 6 measurements. The trial is partly supported by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).

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Organizational Data

  •   DRKS00000302
  •   2009/12/23
  •   [---]*
  •   yes
  •   Approved
  •   2009305, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  •   U1111-1113-0621 
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Health Condition or Problem studied

  •   5-511: Cholecystectomy
  •   K81.1 -  Chronic cholecystitis
  •   K80.2 -  Calculus of gallbladder without cholecystitis
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Interventions/Observational Groups

  •   Group A (conventional cholecystectomy): Beside the 10mm optic trocar in the bellybutton, 3 further trocars are inserted, two 5 mm trocars in the right upper abdomen, and one 10 mm trocar in the left abdomen.
  •   Group B (needlescopic cholecystectomy): The three working trocars all have a diameter of only 3 mm.
  •   Gruppe C (SILS): The Single Port System (SILS(R) by Covidien) is placed in the bellybutton.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Intensity of pain during movement as measured on postoperative days 1 to 3 (in total 6 assessments) using VAS (visual analogue scale, 0 to 10)

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Secondary Outcome

Incidence and severity of perioperative complications || Duration of surgery (in minutes) || Subjective cosmetic result (1 to 5 scale) || Quality of life 10 days after surgery (Gastrointestinaler Quality of Life Index (GIQLI) by Eypasch et al.)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/01/05
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Symptomatic cholecystolithiasis; Indication for elective cholecystectomy; Age >=18 years and legal competence

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Exclusion Criteria

Age > 80 year; Obesity with a Body Mass Index (BMI) > 30 kg/m2; Acute cholecystitis or locally complicated disease (gallbladder empyema, pancreatitis, etc.); Severe comorbidity, defined as American Society for Anesthesiologists (ASA) class IV oder V; Neuromuscular disease interfering with treatment or pain measurements; Chronic abuse of analagesics or alcohol; History of major abdominal surgery with a high risk of intraperitoneal adhesions (Minor operations such as appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. represent no exclusion criterion); Gravidity or breastfeeding; Allergy against analgetics; Patient's dependency to trial sponsor or physicians; Institutionalisation due to legal reasons; Participation in other clinical studies, which might interfere with the present trial; No written informed consent signed

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Addresses

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    • Klinik für Viszeral-, Thorax- und Gefäßchirurgie Kreiskrankenhaus Gummersbach
    • Mr.  Dr. med.  Stefan  Saad 
    • Wilhelm-Breckow-Allee 20
    • 51643  Gummersbach
    • Germany
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    • Institut für Forschung in der Operativen Medizin (IFOM) Universität Witten/Herdecke
    • Mr.  Prof. Dr. med.  Stefan  Sauerland 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Klinik für Viszeral-, Thorax- und Gefäßchirurgie Kreiskrankenhaus Gummersbach
    • Ms.  Verena  Strassel 
    • Wilhelm-Breckow-Allee 20
    • 51643  Gummersbach
    • Germany
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Sources of Monetary or Material Support

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    • gefördert im Rahmen der CHIR-Net-Förderung (Fö.-Kz. 01-GH-0605) des Bundesministeriums für Bildung und Forschung (BMBF)
    • Heinemannstr. 2
    • 53175  Bonn
    • 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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