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Laparoscopic Retrovesical Colpopectinopexia (prolapse)

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
laparoscopic retrovesical colpopectinopexia
Sponsored by
Orel Regional Hospital, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • LISODRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

laparoscopic retrovesical colpopectinopexia

Arm Description

new operative technic

Outcomes

Primary Outcome Measures

POP-Q assessment
assessment of vaginal wall accordion to POP-Q score

Secondary Outcome Measures

POP-Q assessment
assessment of vaginal wall accordion to POP-Q score
POP-Q assessment
assessment of vaginal wall accordion to POP-Q score

Full Information

First Posted
September 26, 2016
Last Updated
September 28, 2016
Sponsor
Orel Regional Hospital, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT02919852
Brief Title
Laparoscopic Retrovesical Colpopectinopexia
Acronym
prolapse
Official Title
Laparoscopic Retrovesical Colpopectinopexia in Treatment Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orel Regional Hospital, Russia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic retrovesical colpopectinopexia
Arm Type
Other
Arm Description
new operative technic
Intervention Type
Procedure
Intervention Name(s)
laparoscopic retrovesical colpopectinopexia
Intervention Description
Laparoscopic correction of pelvic organ prolapse using a mesh in retrovesical space with pectineal ligament fixation.
Primary Outcome Measure Information:
Title
POP-Q assessment
Description
assessment of vaginal wall accordion to POP-Q score
Time Frame
first post operation day
Secondary Outcome Measure Information:
Title
POP-Q assessment
Description
assessment of vaginal wall accordion to POP-Q score
Time Frame
6 month after operation
Title
POP-Q assessment
Description
assessment of vaginal wall accordion to POP-Q score
Time Frame
1 year after operation

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all female with cystocele 1-2-3 grade? hysterocele 1-2 (POP-Q) Exclusion Criteria: rectocele more then 1 grade (POP-Q) hysterocele more then 2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexey Abolmasov, MD,PhD
Phone
+79107478534
Email
abolmasov57@gmail.com
Facility Information:
Facility Name
LISOD
City
Kiev
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Baydo, MD, PhD
Phone
+380504415892
Email
surgyserg@gmail.com
First Name & Middle Initial & Last Name & Degree
Bekhan Khatsiev, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Laparoscopic Retrovesical Colpopectinopexia

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