Trial document




drksid header

  DRKS00003263

Trial Description

start of 1:1-Block title

Title

Use of absorbable versus non-absorbable sutures for vaginal implant fixation during sacrocolpopexy as part of the surgical treatment of vaginal vault prolapse ICS-POPQ stage II-III

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://None

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Sacrocolpopexy is suitable for the treatment of symptomatic vaginal vault prolapse using an interposition graft between vagina and anterior longitudinal ligament (presacral space).The aim of the study is to investigate whether the absorbable sutures used to fixate the implant on the vaginal wall are better than or as good as the non-absorbable suture material.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of our study is to document the anatomical results using the ICS-POPQ System 6 months postoperatively and also to record the patients’ postoperative symptoms. The data collection is achieved by anamnesis, gynecological examination and by way of two standardised questionnaires on the impact on the bladder and bowel function as well as on sexuality and prolapse symptoms.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003263
  •   2011/09/14
  •   [---]*
  •   yes
  •   Approved
  •   144/2011MPG23, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   N99.3 -  Prolapse of vaginal vault after hysterectomy
  •   N94.1 -  Dyspareunia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Mesh fixation at the vaginal wall with resorbable sutures
  •   Mesh fixation at the vaginal wall with non-resorbable sutures
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary target figure is the anatomical success. An anatomical surgical success can be assumed when the vaginal apex (point C/ICS-POPQ) does not descend more than 50% of the vaginal length (tvl) on straining.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

The secondary target figure is the functional parameter: collection of symptomatic/asymptomatic penetration of suture material in the vagina, the state of health of the patient postoperatively using a Likert scale and the effects of surgery on sexuality using the PISQ-12 questionnaire. Assessment of bladder and bowel function as well as sexuality and prolapse symptoms are performed using the German pelvic floor questionnaire.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/09/01
  •   208
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Women over 18 years of age
Symptomatic vaginal vault prolapse ICS-POPQ Stage II-III
Ability to consent
Ability to attend the hospital 6 months postoperatively

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Gynaecological surgery within the last three months
Anticoagulation treatment
Participation in another study or non-interventional study
History of prolapse surgery with implants/transplants
History of pelvic radiotherapy
Immunosuppression, chemotherapy at the time of the study
Patients requiring another concurrent operation e.g. rectopexy, intestinal resection, colpoperineoplasty, anterior colporrhaphy, paravaginal colpopexy, incontinence surgery
Patients with an additional indication for the operative correction of the perineum or concurrent urinary incontinence surgery (concurrent adnexectomy is permitted)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäts-Frauenklinik
    • Ms.  Prof. Dr. med.  Christl  Reisenauer 
    • Calwerstrasse 7
    • 72076   Tübingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitäts-Frauenklinik Tübingen
    • Ms.  Prof. Dr. med.  Christl  Reisenauer 
    • Carerstrasse 7
    • 72076   Tübingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universtäts-Frauenklinik Tübingen
    • Ms.  Prof. Dr. med.  Christl  Reisenauer 
    • Calwerstrasse 7
    • 72076   Tübingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitäts-Frauenklinik
    • Ms.  Prof. Dr. med.  Christl  Reisenauer 
    • Calwerstrasse 7
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.