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OpenTrials
Completed

NCT Number: NCT05715489

Pectopexy Surgery Without 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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Procedure

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

Primary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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