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OpenTrials
Completed

NCT Number: NCT02258230

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

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

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Key information

Conditions

Pelvic Organ Prolapse Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beverly Hills Sunset Surgery Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D mode of the 3D Laparoscopic Video System

Device

Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

2D mode of the 3D Laparoscopic Video System

Device

Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Olympus Corporation of the Americas

Industry

Collaborators

  • International Urogynecology Associates

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 7, 2014
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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