NCT00886223

Brief Summary

The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic sacropexy regarding perioperative data, objective anatomical results and postoperative quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

2 years

First QC Date

April 21, 2009

Last Update Submit

June 23, 2009

Conditions

Vaginal Vault Prolapse

Keywords

vaginal vault prolapse repairrobot-assisted laparoscopic sacropexyrobot-assisted laparoscopic sacrocolpopexyrobotic laparoscopic sacropexy

Outcome Measures

Primary Outcomes (1)

  • Duration of surgery

    during hospitalisation

Secondary Outcomes (4)

  • Complications

    6 months after hospitalisation

  • Anatomical results

    6 months after hospitalisation

  • Quality of life

    6 months after hospitalisation

  • Costs

    6 months after hospitalisation

Study Arms (1)

1

EXPERIMENTAL
Procedure: laparoscopic robot-assisted sacropexy

Interventions

laparoscopic robot-assisted sacropexyPROCEDURE

Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)

Also known as: robotic laparoscopic sacropexy, robot-assisted laparoscopic sacrocolpopexy, robotic laparoscopic sacrocolpopexy
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • vaginal vault prolapse
  • recurrence after vaginal prolapse repair
  • signed consent

You may not qualify if:

  • rectocele
  • BMI \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Aarau

Aarau, 5001, Switzerland

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dimitri Sarlos, MD

    Kantonsspital Aarau, Department of Obsterics and Gynecology

    STUDY CHAIR

Central Study Contacts

Dimitri Sarlos, MD

CONTACT

+41 62 8385065Dimitri.Sarlos@ksa.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

CH(1)