Trial document





This trial has been registered retrospectively.
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  DRKS00004568

Trial Description

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Title

Is anal tamponade worthwhile after Milligan-Morgan hemorrhoidectomy? A randomised controlled trial

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Trial Acronym

Tamponade trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In the treatment of high degree hemorroids, the Milligan-Morgan hemorrhoidectomy is a well-established method. This technique consists of a resection of hemorrhoidal nodes. Wounds are left open for healing. To prevent postoperative bleeding many surgeons insert an anal tampon into the patient's anus. However, others have voiced concerns over anal tamponade, becaused it causes pain and fails to prevent bleeding. In the present study, patients after Milligan-Morgan-hemorrhoidectomy either receive or don't receive anal tamponade, with the decision being left to random assignment. The aim of the study is to prove, whether complete abandonment of anorectal drainage reduces pain without leading to more bleeding complications.

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Brief Summary in Scientific Language

In the operative treatment of 3rd and 4th degree hemorroids, the Milligan-Morgan hemorrhoidectomy is a well-established method. To prevent postoperative bleeding many surgeons insert an anal tampon into the patient's anus. However, possible benefits and harms (e.g. pain) of this measure are a matter of discussion.

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Organizational Data

  •   DRKS00004568
  •   2012/11/27
  •   [---]*
  •   yes
  •   Approved
  •   24/2011, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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

  •   I84 -  Haemorrhoids
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Interventions/Observational Groups

  •   After Milligan-Morgan hemorrhoidectomy a conventional anal tampon is inserted into the anal canal. After the completion of surgery, the tampon is placed in the patient's anorectal transition zone. The tampon remains in place until first stool or up to a maximum of 24h, whichever comes first.
  •   After Milligan-Morgan hemorrhoidectomy no anal tampon is inserted.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome measure is maximum postoperative pain. Patients will be interviewed on the evening of the first postoperative day. The patients records maximum pain using a numerical rating scale (NRS) ranging from 0 to 10.

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Secondary Outcome

Local complication rate, bleeding rate, number of dressing or napkin changes, length of hospital stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/03/29
  •   100
  •   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

Hemorrhoids of 2nd, 3rd or 4th degree; indication of Milligan-Morgan hemorrhoidectomy

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Exclusion Criteria

Non-elective surgery; known hemorrhagic disorders; anticoagulative medication within the last 7 days; previous colorectal carcinoma in patient's history; relevant anorectal comorbidity; neuromuscular disease interfering with pain recordings; missing written informed consent

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Addresses

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    • Helios St.Elisabeth Klinik Oberhausen
    • Mr.  PD Dr.  Mike Ralf  Langenbach 
    • Josefstr. 3
    • 46045  Oberhausen
    • Germany
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    • Institut für Forschung in der Operativen Medizin (IFOM), Universität Witten/Herdecke
    • Mr.  PD Dr.  Stefan  Sauerland 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Helios St.Elisabeth Klinik Oberhausen
    • Mr.  PD Dr.  Mike Ralf  Langenbach 
    • Josefstr. 3
    • 46045  Oberhausen
    • Germany
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    • Helios St.Elisabeth Klinik Oberhausen
    • Mr.  PD Dr.  Mike Ralf  Langenbach 
    • Josefstr. 3
    • 46045  Oberhausen
    • Germany
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Sources of Monetary or Material Support

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    • Helios St.Elisabeth Klinik Oberhausen
    • Mr.  PD Dr.  Mike Ralf  Langenbach 
    • Josefstr. 3
    • 46045  Oberhausen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/01
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Trial Publications, Results and other Documents

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