Pelvic Organ ProlapseprolapseNCT02919852
Laparoscopic Retrovesical Colpopectinopexia
A study testing laparoscopic retrovesical colpopectinopexia in people with Pelvic Organ Prolapse, run by Orel Regional Hospital, Russia at 1 site in Ukraine.
Trial summary
The purpose of this study is to identify whether a new operative technic would be acceptable in female with pelvic organ prolapse. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- laparoscopic retrovesical colpopectinopexia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUkraine
- Study dates
- Sep 2016to Jun 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all female with cystocele 1-2-3 grade? hysterocele 1-2 (POP-Q)
Who cannot join
- rectocele more then 1 grade (POP-Q) hysterocele more then 2
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
LISOD
Kiev, Kyiv City
Sergey Baydo, MD, PhD, +380504415892, surgyserg@gmail.com
Bekhan Khatsiev, MD,PhD
About this study
Official title: Laparoscopic Retrovesical Colpopectinopexia in Treatment Pelvic Organ Prolapse
The purpose of this study is to identify whether a new operative technic would be acceptable in female with pelvic organ prolapse.
Read the detailed description
A new operative technic use to treat pelvic organ prolapse in women. Investigators plan to evaluate the results of procedure in the field of recurrence rate, effectiveness, mortality,morbidity and learning curves.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- laparoscopic retrovesical colpopectinopexia
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic retrovesical colpopectinopexiaProcedure or surgery
Laparoscopic correction of pelvic organ prolapse using a mesh in retrovesical space with pectineal ligament fixation.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic retrovesical colpopectinopexia | Other | new operative technic Receives: Procedure: laparoscopic retrovesical colpopectinopexia |
What is being measured
The primary outcome is the main question the study is designed to answer.
POP-Q assessment
assessment of vaginal wall accordion to POP-Q score
Measured: first post operation day
Secondary outcomes (2)
POP-Q assessment
assessment of vaginal wall accordion to POP-Q score
Measured: 6 month after operation
POP-Q assessment
assessment of vaginal wall accordion to POP-Q score
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionJun 2019 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orel Regional Hospital, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919852
- Sponsor's protocol ID
- AAV 31
- Acronym
- prolapse
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Retrovesical Colpopectinopexia in Treatment Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT02919852
- Acronym / sponsor ID
- prolapse / AAV 31
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Orel Regional Hospital, RussiaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 29 Sep 2016 (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.
The purpose of this study is to identify whether a new operative technic would be acceptable in female with pelvic organ prolapse.
Detailed description
A new operative technic use to treat pelvic organ prolapse in women. Investigators plan to evaluate the results of procedure in the field of recurrence rate, effectiveness, mortality,morbidity and learning curves.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laparoscopic retrovesical colpopectinopexia | Other | Procedure: laparoscopic retrovesical colpopectinopexianew operative technic |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all female with cystocele 1-2-3 grade? hysterocele 1-2 (POP-Q)
Key exclusion criteria (1 listed)
- rectocele more then 1 grade (POP-Q) hysterocele more then 2
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 |
|---|---|---|
| laparoscopic retrovesical colpopectinopexiaLaparoscopic correction of pelvic organ prolapse using a mesh in retrovesical space with pectineal ligament fixation. | Procedure or surgery | laparoscopic retrovesical colpopectinopexia |
Primary outcome
POP-Q assessment
Time frame: first post operation day
assessment of vaginal wall accordion to POP-Q score
2 secondary outcomes
POP-Q assessment
Time frame: 6 month after operation
POP-Q assessment
Time frame: 1 year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic retrovesical colpopectinopexia in people with Pelvic Organ Prolapse, run by Orel Regional Hospital, Russia at 1 site in Ukraine.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexey Abolmasov, MD,PhD (+79107478534, abolmasov57@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POP-Q assessment (time frame: first post operation day). 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 30 Sep 2016.