Clinical Trials Logo
  1. Home
  2. Pelvic Organ Prolapse
  3. NCT02258230
  4. Details
NCT02258230 Clinical Trial

Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair

Pelvic Organ Prolapse Clinical Trial

Official title:
Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02258230
Other study ID # 4859
Secondary ID
Status Completed
Phase N/A
First received October 2, 2014
Last updated April 3, 2018
Start date December 2014
Est. completion date March 2018

Study information
Verified date April 2018
Source Olympus Corporation of the Americas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.

Description:

The purpose of this study is to compare operative times of laparoscopic sacral colpopexy (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic systems. Additionally this study will evaluate postoperative complications from surgeries performed using two-dimensional versus three-dimensional laparoscopic systems.

Recruitment information / eligibility
Status Completed
Enrollment 194
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Symptomatic vaginal vault prolapse (stage 2 or greater point C-1 pelvic organ prolapse quantification [POP-Q] or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic sacral colpopexy

And/Or

- Symptomatic cystocele (stage 2 or greater, point Aa or Ba > -1 POP-Q or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic paravaginal repair

Exclusion Criteria:

- Age less than 18 years

- Inability to comprehend questionnaires

- Inability to give informed consent or to return for review

- Vaginal vault prolapse < stage 2

- Unable to undergo general anesthesia

- More than 5 previous laparotomies

- Prior sacral colpopexy or vaginal mesh prolapse procedure

- Prior surgery involving the retropubic space

- Vaginal length less than 6 cm

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
• 2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Locations
Country Name City State
United States Northside Hospital Atlanta Georgia
United States Beverly Hills Sunset Surgery Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Olympus Corporation of the Americas International Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operative Times Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum. Intraoperative
Secondary Complications Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure. Intraoperative up to 6 weeks post procedure
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
Active, not recruiting NCT05422209 - The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. N/A
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT06126328 - Materna Prep Study Phase II Phase 2
Recruiting NCT05542836 - EVeRLAST 2-Year Follow-Up
Recruiting NCT05918367 - Multicenter Ventral Mesh Rectopexy Registry Collaborative
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Recruiting NCT02919852 - Laparoscopic Retrovesical Colpopectinopexia N/A
Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A

External Links