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临床试验/NCT03146195
NCT03146195Unknown不适用

The 3D Reconstruction Research of Pelvic Organ Prolapse Disease and the Establishment of Assessment for Space Coordinates

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Bladder,uterus and rectum space coordinates.

研究概览

简要总结

Female pelvic organ prolapse (FPOP) is one of the main diseases affecting the quality of life of middle aged and elderly women in non-neoplastic diseases. An aging population makes the incidence of this disease to increase year by year. Surgical operation is the main treatment. While the recurrence rate of classic repair surgery is high, the method of patch implantation reinforces the supporting force, which significantly reduce the recurrence rate. However, this method is costly and is associated with complications which may trigger new symptoms. As such, there is still no perfect surgical method. The main reason for this is that the assessment method of pelvic defects is crude and indirect, which results in the diagnosis of FPOP only representing external problems whereas, inner defected parts are not properly assessed. In recent years, research with the use of 2D and 3D MRI reconstructions on the anus levator muscle and ligament has become a hot topic. It found that the characteristic of the high resolution of soft tissue in the magnetic resonance imaging (MRI) has a big advantage in pelvic floor study.The investigators commenced the study of 3D reconstruction technology based on the MRI datasets in 2009. The investigators have mastered the most common, key technologies of MRI three-dimensional reconstruction. The investigators have done research targeted on the reconstruction methods of the normal pelvis, viscera, ligaments, pelvic floor muscles. This project is aimed at 3D reconstruction of the whole pelvic base on static and dynamic MRI images from FPOP patients, and establish the corresponding space coordinates assessment system to do location and quantitative research of the pelvic viscera and its support structure, thus providing a FPOP diagnosis platform that is more precise, direct and comprehensive.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female who were diagnosed with pelvic organ prolapse by using Pelvic Organ Prolapse Quantification (POP-Q) exams;
  • Without history of pelvic surgery;
  • Could cooperate smoothly with valsalva maneuver.

排除标准

  • Combined with gynecologic malignant tumors;
  • With MRI contraindications;
  • Female who refuse to undergo MRI evaluation.

结局指标

主要结局

Bladder,uterus and rectum space coordinates.

时间窗: september 1,2017 to september 1,2019

levator ani muscle space coordinates.

时间窗: september 1,2017 to september 1,2019

次要结局

  • bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL line(september 1,2016 to september 1,2019)
  • levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle.(september 1,2017 to september 1,2019)
  • Urethral rotation Angle,posterior vesicourethral angle.(september 1,2017 to september 1,2019)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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