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

Not Applicable

Recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: unilateral suture sacro-hysteropexy; Procedure: bilateral suture sacro-hysteropexy

• Registration Number: NCT06341088
• Lead Sponsor: Ataturk University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Study Start: 2024-04-05
• Primary Completion: 2024-07-05
• Study Completion: 2024-10-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unilateral suture sacro-hysteropexy	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	bilateral suture sacro-hysteropexy	patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable sutures and bilaterally suspended to the anterior longitudinal ligament.

Primary Outcome Measures

Name	Time	Method
anatomical success of the operations	changes at 1 and 3 months after surgery	comparition of preoperative and postoperative pelvic organ prolapse quantification system (POP-Q) measurements of the patients

Secondary Outcome Measures

Name	Time	Method
evaluation of the sexual functions of the patients	changes at 1 and 3 months after surgery	comparition of preoperative and postoperative FSFI(female sexual function index) scores of the patients

Trial Locations

Locations (1)

Atatürk University; 🇹🇷 Erzurum, Palandöken, Turkey