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临床试验/NCT05715489
NCT05715489已完成不适用

Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年5月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Pre and post operative assessment of POP-Q measurements

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •having pelvic organ prolapse greater than stage 2 according to POP-Q evaluation system
  • •being sexually active

排除标准

  • •Disease requiring chronic steroid use
  • •Having chronic obstructive pulmonary disease
  • •Having malignancy,
  • •Having metabolic and rheumatological diseases that impair tissue healing, such as scleroderma

研究组 & 干预措施

Patients with pelvic organ prolapse undergone pectopexy without using mesh

Other

干预措施: Comparison of pre and postoperative POP-Q values of the patients (Procedure)

Patients with pelvic organ prolapse undergone pectopexy without using mesh

Other

干预措施: Comparison of pre and postoperative PISQ-12 scores of the patients (Procedure)

结局指标

主要结局

Pre and post operative assessment of POP-Q measurements

时间窗: 2 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Süleyman Salman

Associate Professor

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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