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NCT06341088 Clinical Trial

Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations

Pelvic Organ Prolapse Clinical Trial

Official title:
Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations, a Prospective Randomised Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06341088
Other study ID # B.30.2.ATA.0.01.00/132
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 5, 2024
Est. completion date October 5, 2024

Study information
Verified date March 2024
Source Ataturk University
Contact Gamze Nur Cimilli Senocak
Phone +905305880025
Email gncimilli@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.

Description:

The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.Computerized random number table will be used as randomization method. Patients who agree to participate in the study and fulfill the inclusion criteria will be evaluated on the effects of prolapse on quality of life and sexual function before and after the surgical procedures and their complaints and satisfaction will be questioned. Surgical success and complications will be evaluated. Changes in the level of prolapse will be evaluated.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date October 5, 2024
Est. primary completion date July 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. Patients between the ages of 18-60 2. No previous prolapse surgery 3. Not having a chronic disease 4. Having stage 3-4 prolapse Exclusion Criteria: 1. Outside the age range of 18-60 years 2. Previous prolapse surgery 3. Having early stage (1-2) prolapse 4. History of chronic disease

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• unilateral suture sacro-hysteropexy
patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.
• bilateral suture sacro-hysteropexy
patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable suture and bilaterally suspended to the anterior longitudinal ligament.

Locations
Country Name City State
Turkey Atatürk University Erzurum Palandöken

Sponsors (1)
Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary anatomical success of the operations comparition of preoperative and postoperative pelvic organ prolapse quantification system (POP-Q) measurements of the patients changes at 1 and 3 months after surgery
Secondary evaluation of the sexual functions of the patients comparition of preoperative and postoperative FSFI(female sexual function index) scores of the patients changes at 1 and 3 months after surgery
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