NCT02919852

Brief Summary

The purpose of this study is to identify whether a new operative technic would be acceptable in female with pelvic organ prolapse.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 26, 2016

Last Update Submit

September 28, 2016

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • POP-Q assessment

    assessment of vaginal wall accordion to POP-Q score

    first post operation day

Secondary Outcomes (2)

  • POP-Q assessment

    6 month after operation

  • POP-Q assessment

    1 year after operation

Study Arms (1)

laparoscopic retrovesical colpopectinopexia

OTHER

new operative technic

Procedure: laparoscopic retrovesical colpopectinopexia

Interventions

laparoscopic retrovesical colpopectinopexiaPROCEDURE

Laparoscopic correction of pelvic organ prolapse using a mesh in retrovesical space with pectineal ligament fixation.

laparoscopic retrovesical colpopectinopexia

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all female with cystocele 1-2-3 grade? hysterocele 1-2 (POP-Q)

You may not qualify if:

  • rectocele more then 1 grade (POP-Q) hysterocele more then 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LISOD

Kiev, Kyiv City, Ukraine

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Alexey Abolmasov, MD,PhD

CONTACT

+79107478534abolmasov57@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 29, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

June 1, 2019

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

UA(1)