Laparoscopic Sacropexy With Robot-Assisted Surgical System

NCT ID: NCT00886223

Last Updated: 2009-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Vaginal Vault Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

laparoscopic robot-assisted sacropexy

Intervention Type PROCEDURE

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

Interventions

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laparoscopic robot-assisted sacropexy

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

Intervention Type PROCEDURE

Other Intervention Names

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robotic laparoscopic sacropexy robot-assisted laparoscopic sacrocolpopexy robotic laparoscopic sacrocolpopexy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* rectocele
* BMI \> 40
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kantonsspital Aarau

OTHER

Sponsor Role lead

Responsible Party

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Kantonsspital Aarau

Principal Investigators

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Dimitri Sarlos, MD

Role: STUDY_CHAIR

Kantonsspital Aarau, Department of Obsterics and Gynecology

Locations

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Kantonsspital Aarau

Aarau, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dimitri Sarlos, MD

Role: CONTACT

+41 62 8385065

Other Identifiers

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KSA-RobPex1

Identifier Type: -

Identifier Source: org_study_id

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