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

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ClinicalTrials.gov Identifier: NCT02258230
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
International Urogynecology Associates
Information provided by (Responsible Party):
Olympus Corporation of the Americas

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

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Cystocele Device: 3D mode of the 3D Laparoscopic Video System Device: 2D mode of the 3D Laparoscopic Video System Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications
Actual Study Start Date : December 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2D mode LSC
2D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
Device: 2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Active Comparator: 3D mode LSC
3D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
Device: 3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Active Comparator: 2D mode PVR
2D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
Device: 2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Active Comparator: 3D mode PVR
3D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
Device: 3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.




Primary Outcome Measures :
  1. Operative Times [ Time Frame: Intraoperative ]
    Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.


Secondary Outcome Measures :
  1. Complications [ Time Frame: Intraoperative up to 6 weeks post procedure ]
    Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02258230


Locations
United States, California
Beverly Hills Sunset Surgery Center
Los Angeles, California, United States, 90069
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Olympus Corporation of the Americas
International Urogynecology Associates
Investigators
Principal Investigator: Robert D Moore, DO International Urogynecology Associates

Additional Information:
Responsible Party: Olympus Corporation of the Americas
ClinicalTrials.gov Identifier: NCT02258230     History of Changes
Other Study ID Numbers: 4859
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Cystocele
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases