The 3D Reconstruction Research of Pelvic Organ Prolapse Disease

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03146195
Collaborator
(none)
80
1
63
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dynamic Magnetic resonance imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
The 3D Reconstruction Research of Pelvic Organ Prolapse Disease and the Establishment of Assessment for Space Coordinates
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
POP

Female patients with pelvic organ prolapse,such as: cystocele, uterine prolapse, the vault prolapse, rectal prolapse ,undergo pelvic floor reconstruction surgery.Before and after sugery,take dynamic magnetic resonance imaging scan.

Other: Dynamic Magnetic resonance imaging

Non-POP

Females with normal pelvic floor support,don't need pelvic floor reconstruction surgery,only take once dynamic magnetic resonance imaging scan.

Other: Dynamic Magnetic resonance imaging

Outcome Measures

Primary Outcome Measures

  1. Bladder,uterus and rectum space coordinates. [september 1,2017 to september 1,2019]

  2. levator ani muscle space coordinates. [september 1,2017 to september 1,2019]

Secondary Outcome Measures

  1. bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL line [september 1,2016 to september 1,2019]

  2. levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle. [september 1,2017 to september 1,2019]

  3. Urethral rotation Angle,posterior vesicourethral angle. [september 1,2017 to september 1,2019]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Female who were diagnosed with pelvic organ prolapse by using Pelvic Organ Prolapse Quantification (POP-Q) exams;

  2. Without history of pelvic surgery;

  3. Could cooperate smoothly with valsalva maneuver.

Exclusion Criteria:
  1. Combined with gynecologic malignant tumors;

  2. With MRI contraindications;

  3. Female who refuse to undergo MRI evaluation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital of Southern Medical University Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT03146195
Other Study ID Numbers:
  • NFEC2013032-3
First Posted:
May 9, 2017
Last Update Posted:
May 9, 2017
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Nanfang Hospital of Southern Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2017