- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394237
Laparoscopic Sacrocolpopexy: Long Term Follow-up
March 11, 2014 updated by: Dimitri Sarlos, Kantonsspital Aarau
Laparoscopic Sacrocolpopexy: Long Term Results With Special Focus on Anatomical Results and Quality of Life
The purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life.
Study Overview
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aargau
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Aarau, Aargau, Switzerland, 5001
- Frauenklinik Kantonsspital Aarau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
Description
Inclusion Criteria:
- Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
- consent
Exclusion Criteria:
- no consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Operated by laparoscopic sacrocolpopexy
Patients operated at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
|
Examination of recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment
Time Frame: 3-6 years after surgery
|
Recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system
|
3-6 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 3-6 years after surgery
|
Quality of life as assessed by a specific validated questionnaire
|
3-6 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dimitri Sarlos, MD, Kantonsspital Aarau
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
July 13, 2011
First Submitted That Met QC Criteria
July 13, 2011
First Posted (Estimate)
July 14, 2011
Study Record Updates
Last Update Posted (Estimate)
March 12, 2014
Last Update Submitted That Met QC Criteria
March 11, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SakPexFup
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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