NCT02258230

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

3.2 years

First QC Date

October 2, 2014

Last Update Submit

April 3, 2018

Conditions

Pelvic Organ ProlapseCystocele

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Complications

    Intraoperative up to 6 weeks post procedure

Study Arms (4)

2D mode LSC

ACTIVE COMPARATOR

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

3D mode LSC

ACTIVE COMPARATOR

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

2D mode PVR

ACTIVE COMPARATOR

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

3D mode PVR

ACTIVE COMPARATOR

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

Interventions

3D mode of the 3D Laparoscopic Video SystemDEVICE

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

3D mode LSC3D mode PVR
2D mode of the 3D Laparoscopic Video SystemDEVICE

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

2D mode LSC2D mode PVR

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beverly Hills Sunset Surgery Center

Los Angeles, California, 90069, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Related Links

MeSH Terms

Conditions

Pelvic Organ ProlapseCystocele

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Robert D Moore, DO

    International Urogynecology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 7, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 4, 2018

Record last verified: 2018-04

Locations

US(2)