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临床试验/NCT03857724
NCT03857724Unknown不适用

Clinical and Three-dimensional Ultrasound Assessment of Cases With Apical Prolapse Surgeries. A Prospective Cohort Study

Assiut University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1
试验地点
1
主要终点
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.

研究概览

简要总结

The levator ani muscle seems to play a key role in pelvic floor dysfunction. This muscle has two major components, the pubovisceral (including the pubococcygeus and puborectalis muscles) and the iliococcygeal muscles.Major levator ani defects are associated with pelvic organ prolapse (POP) and POP recurrence

详细描述

The aetiology of female pelvic organ prolapse (FPOP) is complex and likely due to a combination of factors. Genetics, race, aging and menopause, obesity and conditions associated with a chronically increased intra-abdominal pressure such as chronic obstructive pulmonary disease as well as childbirth trauma have been implicated. Delivery-related trauma to the pubovisceral muscle is common and obviously associated with female pelvic organ prolapse.

It is a common problem with an incidence as high as 40%, and 10-20% of women will require surgery for prolapse at least once in their lifetime.

The levator hiatus defines the 'hernial portal' through which FPOP develops. Childbirth clearly leads to an enlargement of the levator hiatus, even in the absence of levator trauma.

And the levator hiatal dimensions are strongly associated with FPOP and with prolapse recurrence Enlargement of the levator hiatus is more likely to be the cause rather than the effect of FPOP. Alterations of the levator hiatus morphology following delivery have been demonstrated using magnetic resonance imaging (MRI) and more recently, three-dimensional (3D) ultrasound imaging Magnetic resonance imaging (MRI) has been shown to visualize levator ani defects effectively, but in recent years, translabial 3- and 4-dimensional (3D/4D) ultrasound has shown to provide valuable information on biometrical properties of the pelvic floor and morphology of the levator ani muscle.And recently three-dimensional ultrasonography is an alternative for MRI in detecting levator defects.

Currently, technologic advances in 3D ultrasonography allow access to the arbitrarily defined planes anywhere within ultrasound volume data and permit direct imaging of the entire levator hiatus.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • I. Arabic female that is able to understand the instructions and the questionnaires that will be given II. Apical prolapse Stage 2-4 (according to POP-Q)(30,33) III. Sexually active (at least 3 times every month)

排除标准

  • Postpartum women during the 1st 6 months postpartum
  • Human papillomavirus vulvar disease (condyloma acuminata)
  • Patient unfit for surgery
  • Previous pelvic reconstruction surgery.
  • Factors affecting healing process as uncontrolled diabetes, steroid therapy, on chemotherapy,..... etc

研究组 & 干预措施

prolapse surgery

Experimental

干预措施: prolapse surgery (Procedure)

结局指标

主要结局

levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.

时间窗: 2 years

levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.

次要结局

未报告次要终点

研究者

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

Andrew Yacoub Shafeek

principal investigator

Assiut University

研究点 (1)

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