Laparoscopic Sacropexy With Robot-Assisted Surgical System (RobPex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886223
Recruitment Status : Unknown
Verified June 2009 by Kantonsspital Aarau.
Recruitment status was:  Recruiting
First Posted : April 22, 2009
Last Update Posted : June 24, 2009
Information provided by:
Kantonsspital Aarau

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.

Condition or disease Intervention/treatment Phase
Vaginal Vault Prolapse Procedure: laparoscopic robot-assisted sacropexy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)
Study Start Date : April 2009
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: 1 Procedure: laparoscopic robot-assisted sacropexy
Repair of vaginal vault prolapse with laparoscopic sacropexy assisted by robotic surgical system (da Vinci®-System)
Other Names:
  • robotic laparoscopic sacropexy
  • robot-assisted laparoscopic sacrocolpopexy
  • robotic laparoscopic sacrocolpopexy

Primary Outcome Measures :
  1. Duration of surgery [ Time Frame: during hospitalisation ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • rectocele
  • BMI > 40

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00886223

Contact: Dimitri Sarlos, MD +41 62 8385065

Kantonsspital Aarau Recruiting
Aarau, Switzerland, 5001
Sponsors and Collaborators
Kantonsspital Aarau
Study Chair: Dimitri Sarlos, MD Kantonsspital Aarau, Department of Obsterics and Gynecology

Responsible Party: Dimitri Sarlos,M.D, Vice chairman, Department of Gynecology and Obsterics, Kantonsspital Aarau Identifier: NCT00886223     History of Changes
Other Study ID Numbers: KSA-RobPex1
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009

Keywords provided by Kantonsspital Aarau:
vaginal vault prolapse repair
robot-assisted laparoscopic sacropexy
robot-assisted laparoscopic sacrocolpopexy
robotic laparoscopic sacropexy

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical