Trial document




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  DRKS00011590

Trial Description

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Title

Randomized controlled trial to investigate the need for tamponde dressing after haemorrhoidectomy.

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Trial Acronym

NoTamp

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URL of the Trial

http://www.notamp.de

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Brief Summary in Lay Language

The NoTamp study is performed to investigate the safety, eligibility and efficiency of a Tamponade after Haemorrhoidectomy. Participation in the study is voluntary. Patient are included german-wide. The normal procedure of a Haemorrhoidectomy is to stop the bleeding with tamponades. This procedure is increasingly beind disregarded. In our study we would like to compare the standard procedure with the treatment without tamponade. Both the standard treatment and the alternative treatment should determine the severity of the pain after operation and how often there is a bleeding within 7 days after surgery, which require surgery again. The patient participating in the study are treated with the standard therapy or with the alternative therapy without tamponde. The duration of the study for each patient is 7 days. After the surgery, the patient are questioned about their pain at different times and with questionnaire about the quality of life.

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Brief Summary in Scientific Language

The study has the aim to show that using no tamponade dressing after haemorrhoidectomy ist not inferior to the use of a tamponade regarding postoperative bleeding.

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Organizational Data

  •   DRKS00011590
  •   2017/04/12
  •   [---]*
  •   yes
  •   Approved
  •   02/2017, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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

  •   K64.2 -  Third degree haemorrhoids
  •   K64.3 -  Fourth degree haemorrhoids
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Interventions/Observational Groups

  •   Haemorrhoideectomy with tamponade
  •   Haemorrhoideectomy without tamponade
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Characteristics

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

1. Max. postoperative pain (elevated by NRS) within 48h after surgery
2. Post-operative bleeding of surgical revesion within 7 days after ectomy

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Secondary Outcome

1. Measurement of pain at the time points 6, 12, 24, 48h,and on Visit 3 and 4.
2. Appllication of analgesics
3. lowest Haemoglobin value within 7 days
4. Query of Quality of life on Visit 1,3 and 4 (EQ5D questionnaire)
5. Query of patient satisfaction on Visit 4 (patient satisfaction questionnaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/04/30
  •   953
  •   Multicenter 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. Haemorhhoides grad 3 and 4 with terminated surgical procedure.
2.greater than or equal 18 years
3.legal capacity
4.written consent form

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Exclusion Criteria

1. pregnancy
2. non-compliance with the study process
3.Participation in other trials
4. Persons who have a dependent relationship to the investigator
5. Inflammatory diseases (anal) such as abscesses, fistula or gangrene

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Addresses

  • start of 1:1-Block address primary-sponsor
    • St. Elisabeth Klinik
    • Mr.  Prof.  Mike Ralf  Langenbach 
    • Josefstr.3
    • 46045  Oberhausen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Forschung in der operativen Medizin (IFOM)Fakultät für Gesundheit der Universität Witten-Herdecke
    • Ms.  Dörthe  Seidel 
    • Ostmerheimerstr. 200
    • 51109  Köln
    • Germany
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    • Klinik für Allgemein-, Viszeralchirurgie und Koloprotokologie.HELIOS St. Elisabeth Klinik Oberhausen
    • Mr.  Prof. Dr.  Mike Ralf  Langenbach 
    • Josefstr.3
    • 46045  Oberhausen
    • Germany
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    • Klinik für Allgemein-, Viszeralchirurgie und Koloprotokologie.HELIOS St. Elisabeth Klinik Oberhausen
    • Mr.  Prof. Dr.  Mike Ralf  Langenbach 
    • Josefstr.3
    • 46045  Oberhausen
    • Germany
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Sources of Monetary or Material Support

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    • HELIOS Forschungförderung
    • Friedrichstr.136
    • 10117  Berlin
    • Germany
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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.