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临床试验/NCT05066737
NCT05066737已完成不适用

Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique

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: 2021年9月1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
Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes

研究概览

简要总结

It was aimed to evaluate the quality of life and sexual function of patients by Pre- and postoperative POP-Q (Pelvic Organ Prolapse Quantification) staging and PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) test of patients who underwent lateral suspension operation with V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique.

详细描述

NOTES technically means a surgical intervention performed by entering the abdomen through one of the body's natural openings such as mouth, anus, vagina, and urethra. With the flexible endoscope, a hole is made in organs such as stomach, colon, vagina, bladder, and the peritoneal cavity is entered and the area to be studied is provided by filling air. With the V-NOTES (vaginal Vaginal-Natural Orifice Transluminal Endoscopic Surgery) method we will apply, we reject the bladder from the cervix and reach to abdominal cavity by piercing the visceral peritoneum. The abdomen will be viewed via trocars placed in this region and a lateral suspension operation, which is a kind of suspension surgery of pelvic organ prolapsus, will be performed.The POP-Q staging that will be performed before the lateral suspension operation with the V-NOTES Technique will be compared with the POP-Q staging 6 after the operation. In addition, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) test will be used for the evaluation of pelvic organ prolapse, urinary incontinence and sexual function in the same intervals.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Patients with more than 2nd and 3rd degree uterine prolapsus
  • •Patients with more than 2nd and 3rd degree cystocele

排除标准

  • •Having endometriosis
  • •Having a history and/ or active pelvic inflammatory disease
  • •Having uterine fibroids
  • •Having an adnexal cyst with risk of malignancy
  • •Being pregnant

研究组 & 干预措施

patients who has pelvic organ prolapse and underwent lateral suspension via V-notes surgery

Experimental

干预措施: lateral suspension via V-NOTES surgery (Procedure)

结局指标

主要结局

Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes

时间窗: 6 months

Assessment of pop-q quantification staging system before and 6 months after lateral suspension performed via V-notes

Incidence of pelvic organ prolapse/urinary Incontinence and sexual function in patients undergone lateral suspension performed via V-Notes

时间窗: 6 months

Assessment of pisq-12 Questionnaire in patients undergone lateral suspension performed via V-Notes

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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