Laparoscopic Sacrocolpopexy: Long Term Follow-up

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitri Sarlos, Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT01394237
First received: July 13, 2011
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Vaginal Vault Prolapse
Other: Examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Laparoscopic Sacrocolpopexy: Long Term Results With Special Focus on Anatomical Results and Quality of Life

Resource links provided by NLM:


Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:
  • Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment [ Time Frame: 3-6 years after surgery ] [ Designated as safety issue: No ]
    Recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 3-6 years after surgery ] [ Designated as safety issue: No ]
    Quality of life as assessed by a specific validated questionnaire


Enrollment: 75
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 13, 2011
Last Updated: March 11, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on July 23, 2014