Pelvic Organ ProlapseNCT02258230
Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
A study testing 3D mode of the 3D Laparoscopic Video System and 2D mode of the 3D Laparoscopic Video System in people with Pelvic Organ Prolapse and Cystocele, run by Olympus Corporation of the Americas at 2 sites in United States.
Trial summary
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Cystocele
- What is being tested?
- 3D mode of the 3D Laparoscopic Video System and 2D mode of the 3D Laparoscopic Video System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Prior sacral colpopexy or vaginal mesh prolapse procedure
- Prior surgery involving the retropubic space
- Vaginal length less than 6 cm
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northside Hospital
Atlanta, Georgia, 30342
Beverly Hills Sunset Surgery Center
Los Angeles, California, 90069
About this study
Official title: Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
Read the 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.
- Conditions
- Pelvic Organ Prolapse, Cystocele
- Being tested
- 3D mode of the 3D Laparoscopic Video System, 2D mode of the 3D Laparoscopic Video System
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D mode of the 3D Laparoscopic Video SystemDevice
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
2D mode of the 3D Laparoscopic Video SystemDevice
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: 3D mode of the 3D Laparoscopic Video System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Times
Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.
Measured: Intraoperative
Secondary outcomes (1)
Complications
Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure.
Measured: Intraoperative up to 6 weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Urogynecology Associates
- Responsible party
- Sponsor
- Investigators
- Robert D Moore, DO, Principal investigator, International Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258230
- Sponsor's protocol ID
- 4859
- Status last verified
- Apr 2018
- First submitted
- 2 Oct 2014
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications
- ClinicalTrials.gov ID
- NCT02258230
- Acronym / sponsor ID
- 4859
- Conditions
- Pelvic Organ Prolapse, Cystocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Collaborators
- International Urogynecology Associates
- Study start
- Dec 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2D mode LSC | Active comparator | Device: 2D mode of the 3D Laparoscopic Video System2D 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. |
| 3D mode LSC | Active comparator | Device: 3D mode of the 3D Laparoscopic Video System3D 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. |
| 2D mode PVR | Active comparator | Device: 2D mode of the 3D Laparoscopic Video System2D 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. |
| 3D mode PVR | Active comparator | Device: 3D mode of the 3D Laparoscopic Video System3D 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D mode of the 3D Laparoscopic Video SystemOlympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope. | Device | 3D mode LSC, 3D mode PVR |
| 2D mode of the 3D Laparoscopic Video SystemOlympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope. | Device | 2D mode LSC, 2D mode PVR |
Primary outcome
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.
1 secondary outcome
Complications
Time frame: Intraoperative up to 6 weeks post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- International Urogynecology Associates' websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Moore, DO principal investigator
International Urogynecology Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D mode of the 3D Laparoscopic Video System and 2D mode of the 3D Laparoscopic Video System in people with Pelvic Organ Prolapse and Cystocele, run by Olympus Corporation of the Americas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Times (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.