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NCT03748693 Clinical Trial

Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:
Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03748693
Other study ID # HYMC-0073-18
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2018
Est. completion date September 2019

Study information
Verified date November 2018
Source Hillel Yaffe Medical Center
Contact Mariana Ordonez, MD
Phone 972-52-3243474
Email malo_mariana@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.

We hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Women with POP undergoing colporrhaphy

- Women undergoing hysterectomy

Exclusion Criteria:

- Autoimmune and connective tissue disorders

- Cancer in genital tract

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hysterectomy
Surgery performed on women with a variety of gynecological indications
• Colporrhaphy
Surgery performed on women with POP

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Immune response in POP Tissue biopsy will analyzed for IMC and compared to control group Two weeks
Primary Cytokine environment in POP Tissue biopsy will analyzed for cytokine environment and compared to control group Two weeks
See also
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Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
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Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
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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
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes 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