Trial document





This trial has been registered retrospectively.
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  DRKS00003703

Trial Description

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Title

Post-Ureteroscopic Lesion Scale (PULS): Validation of the modified Endoluminal Ureteral Injury Scale in 435 patients

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Trial Acronym

PULS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Today, patients with diseases of the ureter and/ or kidney such as urinary stones are often treated by an endoscopic approach. After this type of surgery called "ureteroscopy" superficial or deeper lesions of the ureteral mucosa are common. However, to date no specific classification of endoluminal lesions or injuries of the ureter exists. The "Endoluminal Ureteral Injury Scale" had been presented by the group recently.
In this observational study a linguistically modified version of the score called the "Post-ureteroscopic Lesion Score (PULS)" will be applied to a cohort of 400+ patients treated ureteroscopically. In a subset of patients an analysis of inter-rater reliability between 3 observers will be performed.
At the end of the operations indication for possible ureteral stenting will be made based on individual PULS gradings.
A sonographic follow-up for indirect signs of stricture formation will be performed in all patients starting 1 month after inclusion of the last patient.

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Brief Summary in Scientific Language

Today, ureteroscopic treatment of ureteral or renal pathologies such as stone disease is very common. However, a management-modified organ injury scale for typical endoluminal lesions/ injuries frequently seen in thistype of surgery is lacking and indications for post-ureteroscopic JJ stenting are subject to ongoing discussion.
The "Endoluminal Ureteral Injury Scale" had been proposed by the same group of researchers only recently.
In this observational study a linguistically modified version of the score called the "Post-ureteroscopic Lesion Score (PULS)" will be applied to a cohort of 400 patients treated ureteroscopically. In a subset of 100 patients an analysis of inter-rater reliability between 3 observers will be performed.
At the end of the operations indication for possible ureteral stenting will be made based on individual PULS gradings.
A sonographic follow-up for indirect signs of stricture formation will be performed in all patients starting 1 month after inclusion of the last patient.

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Organizational Data

  •   DRKS00003703
  •   2012/04/27
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   10005/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   S37.1 -  Injury of ureter
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Interventions/Observational Groups

  •   Application of PULS (Post-ureteroscopic Lesion Score) in ureteroscopic patients
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Distribution of PULS (Post-Ureteroscopic Lesion Scale) grades 0 - 5 in a cohort of 400+ ureteroscopic patients

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Secondary Outcome

Inter-rater reliability, late complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/07/01
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Ureteroscopic treatment

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Exclusion Criteria

none

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Chirurgische Universitätsklinik Freiburg Abteilung Urologie
    • Mr.  Dr. med.  Martin  Schoenthaler 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Chirurgische Universitätsklinik Freiburg Abteilung Urologie
    • Mr.  Dr. med.  Martin  Schoenthaler 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Chirurgische Universitätsklinik Freiburg, Abteilung Urologie
    • Mr.  Dr. med.  Martin  Schönthaler 
    • Hugstetter Str. 55
    • 79100  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Universitätsklinik Freiburg Abteilung Urologie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/09/15
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* This entry means the parameter is not applicable or has not been set.