The 3D Reconstruction Research of Pelvic Organ Prolapse Disease

NCT ID: NCT03146195

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Organ Prolapse Normal Pelvic Floor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Dynamic Magnetic resonance imaging

Intervention Type OTHER

Non-POP

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

Dynamic Magnetic resonance imaging

Intervention Type OTHER

Interventions

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Dynamic Magnetic resonance imaging

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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PING LIU, PHD

Role: CONTACT

13725263091

ChunLin CHEN, PHD

Role: CONTACT

13725263051

References

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Tang L, Liang S, Chen C, Feng J, Chen L, Peng C, Liu P. Comparison of urethral parameters in females presenting cystoceles with and without stress urinary incontinence based on dynamic magnetic resonance imaging: are they different? Abdom Radiol (NY). 2024 Aug;49(8):2902-2912. doi: 10.1007/s00261-023-04175-7. Epub 2024 Mar 18.

Reference Type DERIVED
PMID: 38498153 (View on PubMed)

Other Identifiers

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NFEC2013032-3

Identifier Type: -

Identifier Source: org_study_id

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