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Laparoscopic Sacrocolpopexy: Long Term Follow-up

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ClinicalTrials.gov Identifier: NCT01394237
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Vaginal Vault Prolapse Other: Examination

Study Design

Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Laparoscopic Sacrocolpopexy: Long Term Results With Special Focus on Anatomical Results and Quality of Life
Study Start Date : June 2011
Primary Completion Date : October 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Operated by laparoscopic sacrocolpopexy
Patients operated at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
Other: Examination
Examination of recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system
Other Names:
  • exam
  • test
  • assessment


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 3-6 years after surgery ]
    Quality of life as assessed by a specific validated questionnaire


Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
Criteria

Inclusion Criteria:

  • Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
  • consent

Exclusion Criteria:

  • no consent
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394237


Locations
Switzerland
Frauenklinik Kantonsspital Aarau
Aarau, Aargau, Switzerland, 5001
Sponsors and Collaborators
Kantonsspital Aarau
Investigators
Study Director: Dimitri Sarlos, MD Kantonsspital Aarau
More Information

Publications:
Responsible Party: Dimitri Sarlos, Head Gynaecology and oncological Gynaecology, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT01394237     History of Changes
Other Study ID Numbers: SakPexFup
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical