Trial document




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  DRKS00000238

Trial Description

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Title

Transdermal endoscopic sacral nerve stimulation - endoscopic parasacral nerve stimulation as treatment for fecal incontinence

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The etablished treatment of fecal incontinence is to check the conductivity of the pathways in an ambulant intervention under local anasthesia and, in a second step, to temporarely implant an electrode. Over a timecourse of 2 weeks, the patient himself can test, if this neurostimulation could be a durable option.
In this method a thin stimulation needle will be positioned throught the foramina and a small electrode will be implanted.
There are patients that are not eligible for this treatment for anatomical reasons.
The goal of this trial is to use an alternative access to achieve the stimulation of the pelvic nerves. An endoscope is used to identify the nerve and to place the electrode in the right positon

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Brief Summary in Scientific Language

Since the 90s, sacral nerve stimulation has been etablished for the treatment of fecal incontinence. The electic stimulation of branches of the plexus sacralis impoves anal angulation and muscular response of M. ani externus (EAS) by the stimulation of the M. puborectalis.
The etablished treatment of fecal incontinence consists in a testing phase, the peripher nerve evaluation (PNE) followed by the implantation of permantent stimulation electrode if there was an improvement.
The critical point of this treatment is the exact placement of the electrode near the innervating nerves. At our hospital, SNS is implanted throught the foramina of the os sacrum unter CT-controle. If the electrode cannot be placed throught the foramina due to anatomic circumstances this minimal invasive treatment casnnot be ccarried out.
In this trial, an alternative access will be tested.
The stimulation electrode will be implanted parasacrale throught the soft tissue under endoscopic sight.
in the is to check the conductivity of the pathways in an ambulant intervention under local anasthesia and, in a second step, to temporarely implant an electrode. Over a timecourse of 2 weeks, the patient himself can test, if this neurostimulation could be a durable option.
In this method a thin stimulation needle will be positioned throught the foramina and a small electrode will be implanted.
There are patients that are not eligible for this treatment for anatomical reasons.
The goal of this trial is to use an alternative access to achieve the stimulation of the pelvic nerves. An endoscope is used to identify the nerve and to place the electrode in the right positon

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Organizational Data

  •   DRKS00000238
  •   2009/10/14
  •   [---]*
  •   yes
  •   Approved
  •   277/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1111-1242 
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Health Condition or Problem studied

  •   R15 -  Faecal incontinence
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Interventions/Observational Groups

  •   endoscopic percutaneous implantation of a stimulation elektrode
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

-positive peripheral nerve evaluation via electromyogram || -number of indications for permanent SNS || -clinical response to tSNS (temporare SNS): clinical and a significant subjective improvement for the patient (stool diary-score and Wexner-score)

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Secondary Outcome

-number of complications || -duration of intervention || -improvement of anal compression (anal manometry) || -improvement of concomitant urinary incontinence

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/06/01
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

->18 years
-neurogenic fecal incontinence
-muscular fecal incontinence: only small lesion of the sphincter (max. 1/4 of circumference
-Anatomy of the os sacrum, that complicates or prohibits standard-SNS
-signed informed consent

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Exclusion Criteria

-<18 years
-primary neurologic degenerative reason for fecal incontinence
-coagulopathy
-infectons like pneumonia, infection of the urinary tract, infection of soft tissue with danger of bacteriemia
-rectal surgery via abdominal access
-pregnancy

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Addresses

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    • Universitätsklinikum Freiburg Abteilung für Allgemein- und Viszeralchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung für Allgemein- und Viszeralchirurgie
    • Mr.  Dr. med.  Matthias  Goos 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung für Allgemein- und Viszeralchirurgie
    • Mr.  Dr. med.  Matthias  Goos 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg Abteilung für Allgemein- und Viszeralchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
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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.