Three-dimensional Study on the Structural Destruction of Pelvic Anatomy in Cervical Cancer

NCT ID: NCT03155529

Last Updated: 2017-05-16

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

2021-09-30

Brief Summary

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Cervical cancer is one of the most prevalent malignancies in female .To the younger patients, radical hysterectomy which is a standard operation during the earlier and middle therapy stage as well as more effective technique like radiotherapy and chemotherapy give them a longer life expectancy. However, the operation destroys patients' normal pelvic anatomy, nutrient supplements and internal secretion so that postoperative pelvic floor functional dysfunction has a destructive effect for their life. There are tremendous studies on clinical symptoms while few on anatomical changes and the relationship between pelvic floor symptoms and the dysfunction. Two-dimensional Magnetic Resonance Imaging(MRI), transperineal ultrasonography, Urodynamic examination and anorectal manometry are frequently used in the fine-structure varies and pelvic floor function. Now three-dimensional MRI has more advantages in fine change of Pelvic anatomical and space position,as well as clearly showing the relationships between the change and space with the pelvic floor function. Based on an eight-year-study on three-dimensional MRI, we can analyze the postoperational anatomical changes and the relationship between the changes and the dysfunction by combined anatomic parameters which are measured on static-dynamic three- dimensional model with clinical symptoms, transperineal ultrasonography,urodynamic examination and anorectal manometry. We expect our study could provide scientific basis for on protective and repaired measures of pelvic floor.

Detailed Description

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Conditions

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Cervical Cancer Postoperative Pelvic Floor Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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radical hysterectomy group

Using dynamic MRI and 3D reconstruction to assess the effect of RH on pelvic floor muscles and pelvic organs (location and mobility of bladder neck and urethral).

Inclusion Criteria: ①Patients diagnosed as FIGO stage IA2、IB1、IIA1 cervical cancer ; ②Patients diagnosed as FIGO stage IB2、IIA2 cervical cancer, eligible for RH after neoadjuvant chemotherapy; ③Patients diagnosed as FIGO stage IIA endometrial carcinoma; ④Patients didn't have pelvic organ prolapse and urinary incontinence; ⑤Ability to hold Valsalva for dynamic MRI; ⑥Patients aged 20-70 years; ⑦Patients undergone RH surgery; ⑧Informed consent was signed.

Exclusion Criteria:

①With MRI or urodynamic examination contraindication; ②Previously undergone POP or SUI surgery; ③BMI\>30 ④With serious postoperative complications.

radical hysterectomy

Intervention Type PROCEDURE

A standard radical hysterectomy with lymphadenectomy was performed. Static and dynamic MRI were performed. A suggested urodynamic examination was done according to the ICS. A 3D reconstruction technique was used to construct the 3D model of the pelvis, pelvic floor muscle, pelvic organ such as bladder and urethral.

Interventions

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radical hysterectomy

A standard radical hysterectomy with lymphadenectomy was performed. Static and dynamic MRI were performed. A suggested urodynamic examination was done according to the ICS. A 3D reconstruction technique was used to construct the 3D model of the pelvis, pelvic floor muscle, pelvic organ such as bladder and urethral.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

①With MRI or urodynamic examination contraindication; ②Previously undergone POP or SUI surgery; ③BMI\>30 With serious postoperative complications.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Third Affiliated Hospital of Southern Medical University

OTHER_GOV

Sponsor Role collaborator

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

Other Identifiers

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NFEC2013032-0

Identifier Type: -

Identifier Source: org_study_id

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