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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03155529
Enrollment
80
Registered
2017-05-16
Start date
2016-09-30
Completion date
2021-09-30
Last updated
2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Postoperative Pelvic Floor Dysfunction

Keywords

cervical cancer, radical hysterectomy, Postoperative pelvic floor dysfunction, the injure of pelvic floor, Three-dimensional reconstruction, structural destruction of pelvic organs, structural destruction of pelvoic floor

Brief summary

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.

Interventions

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.

Sponsors

The Third Affiliated Hospital of Southern Medical University
CollaboratorOTHER_GOV
Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
levator ani muscle space coordinates.september 3,2017 to september 1,2019

Secondary

MeasureTime frame
Bladder,uterus and rectum space coordinates.september 3,2017 to september 1,2019

Other

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

Countries

China

Contacts

Primary ContactPING LIU, PHD
lpivy@126.com13725263091
Backup ContactChunLin CHEN, PHD
jieru@163.com13725263051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026