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Laparoscopic Sacropexy With Robot-Assisted Surgical System

Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00886223
Acronym
RobPex
Enrollment
30
Registered
2009-04-22
Start date
2009-04-30
Completion date
2011-04-30
Last updated
2009-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Vault Prolapse

Keywords

vaginal vault prolapse repair, robot-assisted laparoscopic sacropexy, robot-assisted laparoscopic sacrocolpopexy, robotic laparoscopic sacropexy

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.

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.

Interventions

PROCEDURElaparoscopic robot-assisted sacropexy

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

Sponsors

Kantonsspital Aarau
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* rectocele * BMI \> 40

Design outcomes

Primary

MeasureTime frame
Duration of surgeryduring hospitalisation

Secondary

MeasureTime frame
Complications6 months after hospitalisation
Anatomical results6 months after hospitalisation
Quality of life6 months after hospitalisation
Costs6 months after hospitalisation

Countries

Switzerland

Contacts

Primary ContactDimitri Sarlos, MD
Dimitri.Sarlos@ksa.ch+41 62 8385065

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026