CClinicalTrials.gg
Status unknownNCT00886223RobPexUpdated Jun 24, 2009

Laparoscopic Sacropexy With Robot-Assisted Surgical System

An interventional study of laparoscopic robot-assisted sacropexy in Vaginal Vault Prolapse, sponsored by Kantonsspital Aarau. Status unknown at 1 site in Switzerland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-24.

Sponsored by Kantonsspital Aarau · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Vaginal vault prolapse is a common finding in Gynecology. Many different approaches for vaginal vault prolapse repair are available. During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynecologic surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic sacropexy techniques.

This prospective clinical study evaluates robot-assisted laparoscopic sacropexy (da Vinci®-System) focusing on peri-operative data, objective anatomical results and postoperative quality of life and compares the results with conventional laparoscopic sacropexy. Pre- peri- and post-operative data are collected using the prolapse quantification system (POP-Q) and the German Pelvic Floor questionnaire. The objective of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalization, quality of life and costs.

02

Conditions studied

  • Vaginal Vault Prolapse

Keywords

  • vaginal vault prolapse repair
  • robot-assisted laparoscopic sacropexy
  • robot-assisted laparoscopic sacrocolpopexy
  • robotic laparoscopic sacropexy
03

In context

Prolapse

676 studies on the registry are indexed under Prolapse; 79 are open to participants now.

This study's planned enrollment of 30 is below the median of 74 across 435 interventional studies indexed under Prolapse.

Browse Prolapse studies →

Lead sponsor

Kantonsspital Aarau is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • rectocele
  • BMI > 40
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

    Procedure: laparoscopic robot-assisted sacropexy

Interventions

  • Procedurelaparoscopic robot-assisted sacropexy

    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

06

What researchers measure

Primary outcomes

  1. Duration of surgery

    Time frame: during hospitalisation

Secondary outcomes

  1. Complications

    Time frame: 6 months after hospitalisation

  2. Anatomical results

    Time frame: 6 months after hospitalisation

  3. Quality of life

    Time frame: 6 months after hospitalisation

  4. Costs

    Time frame: 6 months after hospitalisation

07

Study locations

1 of 1 sites recruiting
  • Kantonsspital Aarau
    Aarau, 5001, Switzerland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00886223
Lead sponsor
Kantonsspital Aarau
First posted
Apr 22, 2009
Start date
Apr 2009
Primary completion
Apr 2011 (estimated)
Completion
Apr 2011 (estimated)
Last update
Jun 24, 2009

Study contacts

Dimitri Sarlos, MD
Contact
Dimitri.Sarlos@ksa.ch
+41 62 8385065
Dimitri Sarlos, MD
study chair · Kantonsspital Aarau, Department of Obsterics and Gynecology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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