Pectopexy Surgery Without Mesh

June 2, 2023 updated by: Süleyman Salman, Gaziosmanpasa Research and Education Hospital

Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Gaziosmanpasa Training and Research Hospital
        • Sub-Investigator:
          • Fatma Ketenci Gencer
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with pelvic organ prolapse undergone pectopexy without using mesh
Procedure: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre and post operative assessment of POP-Q measurements
Time Frame: 2 year
POP-Q values of patients before and after laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse will be compared.
2 year
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
Time Frame: 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.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Investigators

  • Principal Investigator: Suleyman Salman, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Estimated)

May 11, 2024

Study Completion (Estimated)

May 11, 2024

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpaşaTREHy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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