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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03155529
• Other study ID #: NFEC2013032-0
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2017
• Last updated: May 15, 2017
• Start date: September 2016
• Est. completion date: September 2021

Study information

• Verified date: September 2016
• Source: Nanfang Hospital of Southern Medical University
• Contact: PING LIU, PHD
• Phone: 13725263091
• Email: lpivy[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Exclusion Criteria:

?With MRI or urodynamic examination contraindication; ?Previously undergone POP or SUI surgery; ?BMI>30 With serious postoperative complications.

Related Conditions & MeSH terms

• Cervical Cancer
• Postoperative Pelvic Floor Dysfunction
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	The Third Affiliated Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL line		september 3,2017 to september 1,2019
Other	levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle.		september 3,2017 to september 1,2019
Other	Urethral rotation Angle,posterior vesicourethral angle.		september 3,2017 to september 1,2019
Primary	levator ani muscle space coordinates.		september 3,2017 to september 1,2019
Secondary	Bladder,uterus and rectum space coordinates.		september 3,2017 to september 1,2019