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

• Conditions: Cervical Cancer; Postoperative Pelvic Floor Dysfunction
• Interventions: Procedure: radical hysterectomy

• Registration Number: NCT03155529
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Study First Posted: 2017-05-16
• Last Update Posted: 2017-05-16
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
radical hysterectomy group	radical hysterectomy	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.

Primary Outcome Measures

Name	Time	Method
levator ani muscle space coordinates.	september 3,2017 to september 1,2019

Secondary Outcome Measures

Name	Time	Method
Bladder，uterus and rectum space coordinates.	september 3,2017 to september 1,2019

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China