Laparoscopic Sacropexy With Robot-Assisted Surgical System (RobPex)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Kantonsspital Aarau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT00886223
First received: April 21, 2009
Last updated: June 23, 2009
Last verified: June 2009

April 21, 2009
June 23, 2009
April 2009
April 2011   (final data collection date for primary outcome measure)
Duration of surgery [ Time Frame: during hospitalisation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00886223 on ClinicalTrials.gov Archive Site
  • Complications [ Time Frame: 6 months after hospitalisation ] [ Designated as safety issue: No ]
  • Anatomical results [ Time Frame: 6 months after hospitalisation ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 months after hospitalisation ] [ Designated as safety issue: No ]
  • Costs [ Time Frame: 6 months after hospitalisation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Laparoscopic Sacropexy With Robot-Assisted Surgical System
Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vaginal Vault Prolapse
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
Experimental: 1
Intervention: Procedure: laparoscopic robot-assisted sacropexy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • rectocele
  • BMI > 40
Female
18 Years and older
Yes
Contact: Dimitri Sarlos, MD +41 62 8385065 Dimitri.Sarlos@ksa.ch
Switzerland
 
NCT00886223
KSA-RobPex1
No
Dimitri Sarlos,M.D, Vice chairman, Department of Gynecology and Obsterics, Kantonsspital Aarau
Kantonsspital Aarau
Not Provided
Study Chair: Dimitri Sarlos, MD Kantonsspital Aarau, Department of Obsterics and Gynecology
Kantonsspital Aarau
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP