Trial document





This trial has been registered retrospectively.
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  DRKS00004566

Trial Description

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Title

Prospectively randomised multicenter trial on the influence on mesh exposure rates of partially absorbable transobturatoric mesh after surgery for pelvic organ prolapse in the anterior compartment

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Trial Acronym

PARETO-trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Surgical therapy for bladder prolapse is often combined with the implantation of polypropylene meshes in order to sthrengthen the patient´s tissue. One possible complication is that the vaginal tissue above the mesh does not heal completely. Newer meshes have threads that become thinner during the course of time, which may result in better wound healing. The aim of the study is to find out whether this is really true, and furthermore to evaluate long term quality of life and success of the operation. Apart from that, possible risk factors for impaired wound healing are evaluated (body weight, other illnesses, surgical technique, bacteria in the vagina, genetic factors). After a random selection patients will have either the conventional or the new mesh. Before the operation and after 3, 12 and 36 months there is a clinical examination and evaluation of the quality of life by a questionnaire. Both meshes are approved by the MPG (law for medical products).

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Brief Summary in Scientific Language

Surgery for cystoceles have high recurrence rates. Therefore, there is more and more implantation of alloplastic transobturatoric mesh. In up to 25% this may result in mesh exposure in the vaginal wall. Meshes made from partially absorbable material are supposed to reduce exposure rates.

Primary endpoint: is there a reduction of the mesh exposure rate after 12 months by using a partially absorbable mesh?

Secondary endpoint: which other factors have an influence on mesh exposure rates? The following items will be investigated:
patient demographics, characteristics of the vaginal wall (grade of prolifertion, bacterial colonisation, molecular factors like collagens, extracellular matrix proteines), surgical technique (thickness of vaginal wall, length of colpotomy, simultaneous hysterectomy). Furthermore, the influence of the material used on pelvic floor related quality of life and recurrence rate are being evaluated.

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Organizational Data

  •   DRKS00004566
  •   2012/11/29
  •   [---]*
  •   yes
  •   Approved
  •   15-07, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   N81.1 -  Cystocele
  •   N81.2 -  Incomplete uterovaginal prolapse
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Interventions/Observational Groups

  •   Vaginal implantation of a non absorbable polypropylene mesh (Seratom E, company: Serag Wiessner, Naila, Germany)
  •   Vaginal implantation of a partially absorbable polypropylene mesh (Seratom E-PA, company: Serag Wiessner, Naila, Germany)
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Characteristics

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

What: Vaginal mesh exposure rate
Wann: 12 months postoperatively
Wie: vaginale examination: visible parts of the mesh

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Secondary Outcome

Which other factors have an influence on mesh exposure rates? The following factors will be investigates:
preoperatively: patients´charakteristics, proliferation of vaginal epithelium, bacterial colonisation of the vagina, molecularbiologic factors of the vaginal wall (e.g. collagen composition and adherence, extracellular matrix proteines)
intraoperative: surgical technique (thickness of vaginal wall. lenght of colpotomy, simultaneous hysterectomy).
3, 12 and 36 months postoperatively: proliferation of vaginal epithelium, bacterial colonisation of the vagina
Furthermore, the influence of the mesh used on pelvic floor related quality of life will be evaluated, using the "German pelvic floor questionnaire" (Deutscher Beckenbodenfragebogen, Baessler et al. 2004) and on prolapse recurrence rates (vaginal examination). Both items will be tested after 3,12 and 36 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2007/04/30
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients were eligible for participation in the trial when they had a symptomatic cystocele > stage 2 or stage 2 in combination with a considerable lateral defect and risk factors for recurrent POP: chronic obstructive pulmonary disease, chronic obstipation, overweight.

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Exclusion Criteria

age <18 yrs, imcompleted family planning, allergy to polypropylene, previous malignancy of lower urinary tract, genital organs or rectosigmoid, previous mesh implantation, missing informed consent, life expectancy <3 yrs or patients that could not ensure follow up visits over 3 years.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Diakoniekrankenhaus
    • Mr.  Prof. Dr. med.  Dirk  Watermann 
    • Wirthstr. 11
    • 79110  Freiburg
    • Germany
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    • Universitätsfrauenklinik
    • Ms.  Dr. med.  Juliane  Farthmann 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Fa. Serag Wiessner
    • Zum Kugelfang 8-12
    • 95119  Naila
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/01
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Trial Publications, Results and other Documents

  •   Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial. Farthmann J, Watermann D, Niesel A, Fünfgeld C, Kraus A, Lenz F, Augenstein HJ, Graf E, Gabriel B. Int Urogynecol J. 2012 Aug 29. [Epub ahead of print]
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* This entry means the parameter is not applicable or has not been set.