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NCT02919852 Clinical Trial

Laparoscopic Retrovesical Colpopectinopexia

Pelvic Organ Prolapse Clinical Trial

— prolapse  

Official title:
Laparoscopic Retrovesical Colpopectinopexia in Treatment Pelvic Organ Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02919852
Other study ID # AAV 31
Secondary ID
Status Recruiting
Phase N/A
First received September 26, 2016
Last updated September 28, 2016
Start date September 2016
Est. completion date June 2019

Study information
Verified date September 2016
Source Orel Regional Hospital, Russia
Contact Alexey Abolmasov, MD,PhD
Phone +79107478534
Email abolmasov57@gmail.com
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date June 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• laparoscopic retrovesical colpopectinopexia
Laparoscopic correction of pelvic organ prolapse using a mesh in retrovesical space with pectineal ligament fixation.

Locations
Country Name City State
Ukraine LISOD Kiev

Sponsors (1)
Lead Sponsor Collaborator
Orel Regional Hospital, Russia

Country where clinical trial is conducted

Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary POP-Q assessment assessment of vaginal wall accordion to POP-Q score first post operation day Yes
Secondary POP-Q assessment assessment of vaginal wall accordion to POP-Q score 6 month after operation Yes
Secondary POP-Q assessment assessment of vaginal wall accordion to POP-Q score 1 year after operation Yes
See also
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Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
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Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
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Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A
Completed NCT00551993 - Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse N/A