Pectopexy Surgery Without Mesh

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Comparison of pre and postoperative POP-Q values of the patients; Procedure: Comparison of pre and postoperative PISQ-12 scores of the patients

• Registration Number: NCT05715489
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse Measurement (POP-Q) and quality of life of the patient.

Detailed Description

Every gynecological patient with prolapse is evaluated with POP-Q staging. The POP-Q staging to be performed before the laparoscopic pectopexy operation without mesh (performed by using non-melting sutures with natural tissue repair) performed on the patients will be compared with the POP-Q staging that will be performed 6 months after the operation. In addition, the quality of life of patients before and 6 months after the operation will be compared with the incontinence quality of life scale questionnaire of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12).

Study Timeline

• Study Start: 2022-05-11
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-08
• Primary Completion: 2024-05-11
• Study Completion: 2024-05-11
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-28
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• having pelvic organ prolapse greater than stage 2 according to POP-Q evaluation system
• being sexually active

Exclusion Criteria

• Disease requiring chronic steroid use
• Asthma
• Having chronic obstructive pulmonary disease
• Having malignancy,
• Having metabolic and rheumatological diseases that impair tissue healing, such as scleroderma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with pelvic organ prolapse undergone pectopexy without using mesh	Comparison of pre and postoperative PISQ-12 scores of the patients	-
Patients with pelvic organ prolapse undergone pectopexy without using mesh	Comparison of pre and postoperative POP-Q values of the patients	-

Primary Outcome Measures

Name	Time	Method
Pre and post operative assessment of POP-Q measurements	2 year	POP-Q values of patients before and after laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse will be compared.
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual	2 year	Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery.

Trial Locations

Locations (1)

Gaziosmanpasa Training and Research Hospital; 🇹🇷 Istanbul, Turkey