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
  Purpose

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 Intervention
Vaginal Vault Prolapse
Procedure: laparoscopic robot-assisted sacropexy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)

Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:
  • Duration of surgery [ Time Frame: during hospitalisation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • rectocele
  • BMI > 40
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886223

Contacts
Contact: Dimitri Sarlos, MD +41 62 8385065 Dimitri.Sarlos@ksa.ch

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

No publications provided

Responsible Party: Dimitri Sarlos,M.D, Vice chairman, Department of Gynecology and Obsterics, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT00886223     History of Changes
Other Study ID Numbers: KSA-RobPex1
Study First Received: April 21, 2009
Last Updated: June 23, 2009
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on September 16, 2014