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临床试验/NCT06000215
NCT06000215已完成不适用

Credibility of Ultrasound Detection of Female Genital Prolapse Mesh

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Precision of mesh detection

研究概览

简要总结

The aim of the study is to investigate the credibility of ultrasound in detection of synthetic polypropylene vaginal implants. In detail, the study investigates if the ultrasound examiner experience and the standard method of examination may affect the detection of synthetic polypropylene vaginal implants by ultrasound.

The primary hypothesis is if 90% of prolapse mesh could be detected by the ultrasound examiners who are blinded to the previous prolapse surgery, the ultrasound is credible for prolapse mesh detection.

The secondary hypothesis is if the ultrasound detection is not significantly different between the ultrasound examiners, the method of ultrasound examination is mandatory to acheive credible ultrasound detection of the prolapse mesh.

详细描述

Pelvic organ prolapse (POP) is a common condition in post-delivery and post-reproductive aged women (1). The lifetime risk of undergoing a single operation for prolapse or incontinence by age 80 is 11% (2). POP is mainly classified into three compartments: anterior, middle (apical) or posterior (1). Apical defects include descensus uteri or vaginal vault prolapse after previous hysterectomy. Traditional Surgical repairs of POP using native connective tissues are commonly used but the risk for POP recurrence is high if apical prolapse is present (ca 60%) (1). Thus, the development of different mesh types using different approaches to support the vaginal apex (uterus or vaginal top) is highly growing. Surgery may be done by transvaginal mesh (TVM) or robotic-assisted sacroclpopexy (3). Increasing evidence show effectivity of both methods and improved HR-QoL after surgery (4, 5, 6, 7, 8, 9). However, PFD including urinary incontinence, urinary bladder emptying disorders and prolapse recurrence may be postoperative conditions (1, 2).

Growing needs worldwide is to improve diagnostic methods such as ultrasonography (US). This may improve the clinical knowledge to be further used for management of pelvic floor disorders (PFD). US is a cheap and safe method as compared to magnetic resonance (MR) or computed tomography (CT) (10). Thus, if using US to provide clinical examination instead of MR and CT the health care cost may be reduced. Indeed, US can provide imaging in some cross sections giving same imaging results of MR (10).

Some studies have been investigating the use of endo-vaginal, trans-perineal/introital and trans-labial US techniques in detection of implants with more focus on TVT-surgery (Tension-free vaginal tape) for urinary incontinence (UI) and to some extent detection of prolapse mesh (11). However, sensitivity of depiction has been reported to 92% at rest and 72% on physical examination when using endovaginal US examination (11). Also, the depiction is dependent on the US expertise since no standardization has been achieved. Furthermore, the presence of scar tissues following previous POP or UI surgery in the pelvic floor region has been described as an interrupting factor for prediction (10).

Thus, development of a standardized US prediction of implants in order to elucidate anatomical and functional information in the pelvic floor when POP mesh is implanted may be useful in management of PFD. It is to investigate the sensitivity and reproducibility of this US model of examination.

The purpose of the present study is to investigate the credibility of the US detection of prolapse mesh implants when a standardized method of US examination is performed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients operated by one of the procedures mentioned
  • Anterior TVM (Uphold™ Lite Vaginal mesh - Boston Scientific.
  • Posterior POP mesh (Pinnacle posterior - Boston Scientific or equal)
  • Y-shaped mesh via robotic assisted sacroclpopexy (Artisyn® Y-Shaped Mesh - Ethicon or equal). and
  • patients received anterior and/or posterior colporraphy i.e. native tissue repair i.e. no synthetic materials used (control group).
  • All patients should have suffered prolapse symptoms before surgery such as pelvic heaviness and/or vaginal bulging, extra.
  • Being able to make an informed consent on participation
  • Physically and cognitively capable of participating in the examination
  • No exclusion criteria fulfilled

排除标准

  • Patients operated by different procedures t.ex. two different mesh types
  • Advanced procedure in the pelvic floor such as current pelvic organ cancer (regardless of treatment)
  • Other clinically relevant pelvic disorders for which surgery with other materials (not polypropylene mesh) was previously provided.

结局指标

主要结局

Precision of mesh detection

时间窗: Maximum of 10 minutes for all examination

Being informed of which surgery, examiners are to separately measure the midsagittal lengths of the mesh.

Detection of which mesh without being informed of previous surgery

时间窗: Maximum of 10 minutes for all examination

Without being informed of previous surgery, examiners are to separately diagnose which mesh vs no mesh

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

Edward Morcos

MD, PhD. Senior Consultant.

Karolinska Institutet

研究点 (1)

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