Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000602

Trial Description

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Title

Inguinal hernia repair by totally extraperitoneal (TEP) approach - a randomised controlled trial comparing standard and mini-instruments

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Trial Acronym

Mini-TEP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

If surgical repair of a groin hernia is done by the TEP technique (totally extraperitoneal), this involves endoscopic implantation of a mesh prosthesis. This trial compares two different sizes of instruments. In one group, two trocars of 3mm size are used, whereas patients in the other group are operated through two trocars of 5 and 10 mm. The third trocar has the standard size of 10 mm in both groups. A possible advantage of smaller-sized instruments might be less pain after surgery, which is the study hypothesis. The study is open for adults, in whom the surgical removal of the gallbladder is indicated because of gallbladder stones (excluding emergency cases).

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Brief Summary in Scientific Language

One popular surgical technique for inguinal hernia repair is the TEP technique (totally extraperitoneal). This technique includes endoscopic access through the layers of the abdominal wall, without entering the abdominal cavity. The hernia is being closed by means of a mesh prosthesis. In all patients in this trial, a 10x15 cm flat polypropylene mesh will be implanted. This randomised controlled trial aims at comparing two sizes of instruments. In the intervention group, mini-instruments (two 3mm working trocars, one 10mm optical trocar) will be used. In the control group, surgery will be performed by standard size instruments (one 10 mm and one 5 mm working trocar, one 10 mm optical trocar). Trocar positioning will be identical in both groups. The aim of the trial is to assess whether minimizazion of surgical access trauma allows to reduce postoperative pain.

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Organizational Data

  •   DRKS00000602
  •   2010/11/02
  •   [---]*
  •   yes
  •   Approved
  •   2009403, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K40.90 -  [generalization K40.9: Unilateral or unspecified inguinal hernia, without obstruction or gangrene]
  •   K40.20 -  [generalization K40.2: Bilateral inguinal hernia, without obstruction or gangrene]
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Interventions/Observational Groups

  •   Inguinal hernia repair in totally extraperitoneal (TEP) technique using miniaturized instruments (optical trocar 10mm, both working trocars 3mm)
  •   Inguinal hernia repair in totally extraperitoneal (TEP) technique using standard size instruments (optical trocar 10mm, working trocars 10 and 5mm)
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Characteristics

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

The primary endpoint of the trial is the level of postoperative pain during the first 7 postoperative days. The intensity of pain in the abdominal area will be measured during movement or coughing by using the visual analogue scale (VAS). Blinded with regard to group assignment, patients will record their level of pain in the range between 0 (no pain) and 100 (worst imaginable pain). In total, 7 VAS values will be recorded from postoperative day 1 to 7, which means that pain on the day of surgery itself is not part of the primary endpoint.

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Secondary Outcome

Analgesic consumption exceeding the standard regimen (recorded from 1st to 7th postoperative day); duration of surgery; incidence of local complications, such as hematoma, seroma or nerve lesion (recorded from surgery until 7th postoperative day); patient satisfaction with cosmetic result (0-to-5 scale, assessed on 7th day and after 3 and 6 months); length of hospital stay; incidence and severity of chronic pain (after 3 and 6 months, measured on Short-Form McGill Pain Questionnaire-2)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/09/01
  •   120
  •   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

Uni- or bilateral primary or recurrent inguinal hernia; indication of surgical repair; age ≥ 18 years; legal competence

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Exclusion Criteria

Scrotal hernia; irreponible, incarcerated hernia; previous inguinal hernia repair by minimally-invasive approach (TEP or TAPP); previous laparotomy of the lower abdomen (excluding appendectomy); planned additional operation (excluding repair of contralateral hernia); body mass index (BMI) > 35 kg/m2; severe comorbidity (ASA IV or V); allergy or intolerance for paracetamol, dipidolor, or polypropylene; chronic alcohol or analgesics abuse; neuromuscular disease; pregancy or lactation; relationship of dependence concerning study staff; imprisonment or committment to an institution; participation in another interfering trial; previous participation in the present trial (for bilateral hernia); lack of written informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Viszeral-, Thorax- und Gefäßchirurgie, Kreiskrankenhaus Gummersbach GmbH
    • Mr.  Prof. Dr.  Stefan  Saad 
    • Wilhelm-Breckow-Allee
    • 51643  Gummersbach
    • Germany
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    • Klinik für Viszeral-, Thorax- und Gefäßchirurgie, Kreiskrankenhaus Gummersbach GmbH
    • Mr.  Prof. Dr.  Stefan  Saad 
    • Wilhelm-Breckow-Allee
    • 51643  Gummersbach
    • Germany
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    • Klinik für Viszeral-, Thorax- und Gefäßchirurgie, Kreiskrankenhaus Gummersbach GmbH
    • Mr.  Dr.  Carsten  Martin 
    • Wilhelm-Breckow-Allee
    • 51643  Gummersbach
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Viszeral-, Thorax- und Gefäßchirurgie, Kreiskrankenhaus Gummersbach GmbH
    • Wilhelm-Breckow-Allee
    • 51643  Gummersbach
    • Germany
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    • CHIR-Net (BMBF Fö.-Kz. 01-GH-0605), c/o Institut für Forschung in der Operativen Medizin (IFOM), Universität Witten/Herdecke
    • Ostmerheimer Str. 200
    • 51109  Köln
    • 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.