Pectopexy Surgery Without Mesh

Sponsor
Gaziosmanpasa Research and Education Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05715489
Collaborator
(none)
34
1
1
12
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Comparison of pre and postoperative POP-Q values of the patients
  • Procedure: Comparison of pre and postoperative PISQ-12 scores of the patients
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh
Actual Study Start Date :
May 11, 2022
Anticipated Primary Completion Date :
May 11, 2023
Anticipated Study Completion Date :
May 11, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pre and post operative assessment of POP-Q measurements [1 year]

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

  2. Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual [1 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gaziosmanpasa Training and Research Hospital Istanbul Turkey

Sponsors and Collaborators

  • Gaziosmanpasa Research and Education Hospital

Investigators

  • Principal Investigator: Suleyman Salman, Saglik Bilimleri Universitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
S├╝leyman Salman, Associate Professor, Gaziosmanpasa Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT05715489
Other Study ID Numbers:
  • Gaziosmanpa┼čaTREHy
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023