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NCT06176521 Clinical Trial

Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:
Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06176521
Other study ID # GaziosmanpasaTREHs
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date November 1, 2024

Study information
Verified date November 2023
Source Gaziosmanpasa Research and Education Hospital
Contact Süleyman Salman, Professor
Phone +90 5059345470
Email sleymansalman@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of the anatomical and functional results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without using mesh in the surgical treatment of pelvic organ prolapse

Recruitment information / eligibility
Status Recruiting
Enrollment 35
Est. completion date November 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. being 18 years old or older 2. needing an operation for symptomatic pelvic organ prolapse - Exclusion Criteria: 1. past history of chemotherapy or radiotherapy 2. past history of pelvic organ prolapse surgery 3. if there is a contraindication of laparoscopy -

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh
Comparison of pre and postoperative POP-Q values of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy SurgeriesWithout Using Mesh Comparison of pre and postoperative PISQ-12 scores of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Without Using Mesh

Locations
Country Name City State
Turkey Gaziosmanpasa Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pre and post operative assessment of POP-Q measurements POP-Q values of patients before and after laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh on Pelvic Organ Prolapse will be compared. 1 year
Primary Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery. 1 year
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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