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Clinical Trials/NCT03146195
NCT03146195
Unknown
Not Applicable

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

Nanfang Hospital, Southern Medical University1 site in 1 country80 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Nanfang Hospital, Southern Medical University
Enrollment
80
Locations
1
Primary Endpoint
Bladder,uterus and rectum space coordinates.
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
December 2021
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Bladder,uterus and rectum space coordinates.

Time Frame: september 1,2017 to september 1,2019

levator ani muscle space coordinates.

Time Frame: september 1,2017 to september 1,2019

Secondary Outcomes

  • 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)

Study Sites (1)

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