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Subjective and objective outcome after laparoscopic sacrocolpopexy

Completed
Conditions
(recidief) prolaps
recurrent vaginal prolapse
vaginal vault prolapse
10038612
10029903
Registration Number
NL-OMON42649
Lead Sponsor
Diakonessenhuis Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
189
Inclusion Criteria

- Patients who underwent a laparoscopic sacrocolpopexy in the period from August 2004 to December 2014 in Diakonessenhuis Utrecht/Zeist
- With good understanding of the Dutch language and willing to complete the validated questionnaire
- Willing to participate in a outpatient clinic visit to undergo a gynaecological examination.

Exclusion Criteria

A potential subject who meets not any of the above mentioned inclusion criteria will be excluded from participation in this study: insufficient understanding of Dutch language and not willing to sign informed consent.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Subjective effectiveness of the laparoscopic sacrocolpopexy: by evaluating the<br /><br>validated questionnaire filled in by the eligible patients. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- objective effectiveness bij gynaecological examination<br /><br>- safety of the procedure by evaluating the per- and postoperative<br /><br>complications.<br /><br>- evaluating the actual quality of life, remaining or new urogynaecologic<br /><br>symptoms and signs 1-11 years postsurgery by a validated questionnaire. </p><br>
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