Pectopexy Surgery Without Mesh

Sponsor

Gaziosmanpasa Research and Education Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05715489

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

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
Pelvic Organ Prolapse	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

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

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.
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:

Süleyman Salman, Associate Professor, Gaziosmanpasa Research and Education Hospital

ClinicalTrials.gov Identifier:

NCT05715489

Other Study ID Numbers:

GaziosmanpaşaTREHy

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:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Feb 8, 2023