Clinical trial NCT03155529: Three-dimensional Study on the Structural Destruction of Pelvic Anatomy in Cervical Cancer
Official title: Three-dimensional Study on the Structural Destruction of Pelvic Organs and Pelvic Floor After Radical Hysterectomy in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Southern Medical University
First posted: 2017-05-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: levator ani muscle space coordinates.
timeFrame: september 3,2017 to september 1,2019
Secondary outcomes:
measure: Bladder，uterus and rectum space coordinates.
timeFrame: september 3,2017 to september 1,2019
Other outcomes:
measure: bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL line
timeFrame: september 3,2017 to september 1,2019
measure: levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle.
timeFrame: september 3,2017 to september 1,2019
measure: Urethral rotation Angle,posterior vesicourethral angle.
timeFrame: september 3,2017 to september 1,2019
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: