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NCT05715489 Clinical Trial

Pectopexy Surgery Without Mesh

Pelvic Organ Prolapse Clinical Trial

Official title:
Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05715489
Other study ID # GaziosmanpasaTREHy
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 11, 2022
Est. completion date May 11, 2024

Study information
Verified date June 2023
Source Gaziosmanpasa Research and Education Hospital
Contact Suleyman Salman
Phone +905059345470
Email sleymansalman@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 34
Est. completion date May 11, 2024
Est. primary completion date May 11, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Turkey Gaziosmanpasa Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2 year
Primary 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. 2 year
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