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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02258230

Enrollment

194

Registered

2014-10-07

Start date

2014-12-31

Completion date

2018-03-31

Last updated

2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystocele, Pelvic Organ Prolapse

Brief summary

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

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.

Interventions

DEVICE3D mode of the 3D Laparoscopic Video System

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

DEVICE2D mode of the 3D Laparoscopic Video System

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Operative Times	Intraoperative	Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.

Secondary

Measure	Time frame	Description
Complications	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026