Pectopexy Surgery Without Mesh

NCT ID: NCT05715489

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2024-05-11

Brief Summary

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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

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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).

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with pelvic organ prolapse undergone pectopexy without using mesh

Group Type OTHER

Comparison of pre and postoperative POP-Q values of the patients

Intervention Type PROCEDURE

Pectopexy Without Using Mesh will be applied to the patients and POP-Q values will be compared pre and postoperatively

Comparison of pre and postoperative PISQ-12 scores of the patients

Intervention Type PROCEDURE

Pectopexy Without Using Mesh will be applied to the patients and PISQ-12 scores will be compared pre and postoperatively

Interventions

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Comparison of pre and postoperative POP-Q values of the patients

Pectopexy Without Using Mesh will be applied to the patients and POP-Q values will be compared pre and postoperatively

Intervention Type PROCEDURE

Comparison of pre and postoperative PISQ-12 scores of the patients

Pectopexy Without Using Mesh will be applied to the patients and PISQ-12 scores will be compared pre and postoperatively

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Süleyman Salman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suleyman Salman

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Gaziosmanpasa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GaziosmanpaşaTREHy

Identifier Type: -

Identifier Source: org_study_id

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