NCT01394237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

July 13, 2011

Last Update Submit

March 11, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment

    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 Outcomes (1)

  • Quality of life

    3-6 years after surgery

Study Arms (1)

Operated by laparoscopic sacrocolpopexy

Patients operated at our institution by laparoscopic sacrocolpopexy between 2003 and 2007

Other: Examination

Interventions

Examination of recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system

Also known as: exam, test, assessment
Operated by laparoscopic sacrocolpopexy

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frauenklinik Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

Related Publications (1)

  • Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. doi: 10.1007/s00192-008-0657-0. Epub 2008 Jun 7.

    PMID: 18536861BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Dimitri Sarlos, MD

    Kantonsspital Aarau

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Gynaecology and oncological Gynaecology

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 14, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations