Back to results

Pectopexy Surgery Without Mesh

Primary Purpose

Pelvic Organ Prolapse

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Gaziosmanpasa Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with pelvic organ prolapse undergone pectopexy without using mesh

Arm Description

Outcomes

Primary Outcome Measures

Pre and post operative assessment of POP-Q measurements

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

Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery.

Secondary Outcome Measures

Full Information

NCT ID

NCT05715489

First Posted

January 18, 2023

Last Updated

June 2, 2023

Sponsor

Gaziosmanpasa Research and Education Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05715489

Brief Title

Pectopexy Surgery Without Mesh

Official Title

Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 11, 2022 (Actual)

Primary Completion Date

May 11, 2024 (Anticipated)

Study Completion Date

May 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with pelvic organ prolapse undergone pectopexy without using mesh

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Pre and post operative assessment of POP-Q measurements

Description

POP-Q values of patients before and after laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse will be compared.

Time Frame

2 year

Title

Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual

Description

Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery.

Time Frame

2 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suleyman Salman

Phone

+905059345470

sleymansalman@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Fatma Ketenci Gencer

Phone

05416116469

fathma_k@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suleyman Salman

Organizational Affiliation

Saglik Bilimleri Universitesi

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gaziosmanpasa Training and Research Hospital

City

Istanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suleyman Salman

Phone

+905059345470

sleymansalman@gmail.com

First Name & Middle Initial & Last Name & Degree

Fatma Ketenci Gencer

Phone

+905416116469

fathma_k@hotmail.com

First Name & Middle Initial & Last Name & Degree

Fatma Ketenci Gencer

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Pectopexy Surgery Without Mesh

We'll reach out to this number within 24 hrs