Trial document





This trial has been registered retrospectively.
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  DRKS00000073

Trial Description

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Title

A prospective randomised trial comparing two different skin closure techniques following ileostomy closure.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

This study compares two different skin closure techniques following ileostomy closure. A complete, linear skin closure will be compared with a circular skin closure, in which the wound remains centrally open for 1 - 1,5 cm. The two methods will be compared regarding the rate of wound infection following the operation, and regarding theis cosmetic result.

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Brief Summary in Scientific Language

Stoma closure is one the most common procedures in the colorectal surgery. With a rate of up to 40 % wound infection is the most common complication after this procedure. The wound is usually closed completely in a linear manner. 2002 Sutton and his co-workers described a circular wound closrue technique, in which the wound remains centrally open for 1 to 1,5 cm. In their work the wound infection rate was 0 %. In the literature there is no prospective, randimised comparison of the two methods. The primary aim of this study is to compare the two techniques regarding the wound infection rate. In addition the cosmetic result following the two techniques will be evaluated after one and six months following the operation.

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Organizational Data

  •   DRKS00000073
  •   2009/01/26
  •   [---]*
  •   yes
  •   Approved
  •   2008-280N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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

  •   Colorectal diseases with the presence of an Ileostomy
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Circular skin closure
  •   linear complete skin closure
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Characteristics

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

Rate of wound infection
Definition of wound infection: Inflammation of the skin, sectretion of pus or unclear fluid, opening of the wound, antibiotic therapy
This will be examined on the 3 ± 1 postoperative day, at discharge, on 30 ± 2 days after the operation

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Secondary Outcome

Cosmetic result: 1 month and 6 months after the operation the cosmetic outcome of the wound will be examined in both groups. The cosmetic result will be examined based on two cosmetic scales: -Body Image Questionnaire-, and the patient scale of the -Patient and Observer Scar Assessment Scale-.

In addition the lenght of skin closure in minutes, the lenght of the operation in minutes, the postoperative hospital stay in days and the effects of age, gender, nicotin and alcohol consumption, Diabetes, Cortison, BMI, Albumin i.S on the rate of wound infection will be assessed.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2008/12/01
  •   80
  •   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

1) Patients with a planned ileostomy closure
2) Patient compliance
3) Informed consent

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Exclusion Criteria

1) Lack of informed consent
2) Participation in other clinical trials

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Addresses

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    • Universitätsmedizin Mannheim, Chirurgische Kliniks
    • Theodor Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
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    •   + 49 621 383 2225
    •   + 49 621 383 1922
    •   [---]*
    •   [---]*
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    • Chirurgische Klinik Universitätsmedizin Mannheim
    • Ms.  Dr. med.  Niloufar  Aramin 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Chirurgische Klinik Universitätsmedizin Mannheim
    • Ms.  Dr. med.  Niloufar  Aramin 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Mannheim, Chirurgische Klinik
    • Theodor Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
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    •   + 49 621 383 2225
    •   + 49 621 383 1922
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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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.