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

May 15, 2017 updated by: Nanfang Hospital of Southern Medical University

Three-dimensional Study on the Structural Destruction of Pelvic Organs and Pelvic Floor After Radical Hysterectomy in Cervical Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

This is a study comparing 70 cases (cervical cancer patients before RH surgery) to 70 controls (Same group cervical cancer patients before RH surgery) exams.All recruits will undergo the MRI evaluation,transperineal ultrasonography, urodynamic examination and anorectal manometryand the basic information of them will be recorded.

Description

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 With serious postoperative complications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
levator ani muscle space coordinates.
Time Frame: september 3,2017 to september 1,2019
september 3,2017 to september 1,2019

Secondary Outcome Measures

Outcome Measure
Time Frame
Bladder，uterus and rectum space coordinates.
Time Frame: september 3,2017 to september 1,2019
september 3,2017 to september 1,2019

Other Outcome Measures

Outcome Measure
Time Frame
bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL line
Time Frame: september 3,2017 to september 1,2019
september 3,2017 to september 1,2019
levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle.
Time Frame: september 3,2017 to september 1,2019
september 3,2017 to september 1,2019
Urethral rotation Angle,posterior vesicourethral angle.
Time Frame: september 3,2017 to september 1,2019
september 3,2017 to september 1,2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

The Third Affiliated Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC2013032-0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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