Laparoscopic Sacropexy With Robot-Assisted Surgical System

Vaginal Vault Prolapse Clinical Trial

— RobPex  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00886223
• Other study ID #: KSA-RobPex1
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2009
• Last updated: June 23, 2009
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2009
• Source: Kantonsspital Aarau
• Contact: Dimitri Sarlos, MD
• Phone: +41 62 8385065
• Email: Dimitri.Sarlos[@]ksa.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• vaginal vault prolapse

• recurrence after vaginal prolapse repair

• signed consent

Exclusion Criteria:

• rectocele

• BMI > 40

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Vaginal Vault Prolapse

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of surgery		during hospitalisation	Yes
Secondary	Complications		6 months after hospitalisation	No
Secondary	Anatomical results		6 months after hospitalisation	No
Secondary	Quality of life		6 months after hospitalisation	No
Secondary	Costs		6 months after hospitalisation	No