A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer

Study Overview
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Brief Summary
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The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Nerve-spring radical hysterectomy
* Procedure: radical hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FIGO(2009) stage Ia2, Ib1, and IIa1 Untreated cervical cancer OR FIGO(2009) stage Ib2 and IIa2 cervical cancer that possible to surgery after neoadjuvant chemotherapy Possible to radical hysterectomy or nerve-spring radical hysterectomy Age: 17 to 60 years No complication during operation Written informed consent Exclusion Criteria: patients who underwent radiotherapy Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma Patients who have uncontrolled diabetes or uncontrolled hypertension patients with neurogenic bladder dysfunction patients with uterine prolapse Patients with psychiatric illness Patients who have active infection Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSRH<br>patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH) | Procedure: Nerve-spring radical hysterectomy<br>* Nerve-spring radical hysterectomy that is reserve some pelvic autonomic nerves during radical hysterectomy. Reserve hypogastric nerve trunk during dissecting cardinal ligament. Reserve pelvic splanchnic nerve trunk during exsecting uterosacral ligament. Reserve bladder nerve of pelvic plexus during dissecting vesicouterine ligament.<br>|
| Active Comparator: RH<br>patients in Arm RH undergo radical hysterectomy (RH) | Procedure: radical hysterectomy<br>* Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum flow rate measured by Urodynamic at 6 months postoperative |  | on 6 months postoperative | 
| residual volume measured by Urodynamic at 6 months postoperative |  | on 6 months postoperative | 
| maximum vesical compliace measured by Urodynamic at 6 months postoperative |  | on 6 months postoperative | 
| cystometric capacity at first desire measured by Urodynamic at 6 months postoperative |  | on 6 months postoperative | 
| maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative |  | on 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (days) to residual urine volume less than 100ml postoperative |  | from operation to residual urine volume less than 100ml, assessed up to 30 days | 
| time (hours) to break wind postoperative |  | from operation to have the first break wind, assessed up to 72 hours | 
| time (hours) to defecation postoperative |  | from operation to have the first defection, assessed up to 72 hours | 
| Number of participants with adverse events |  | From date of operation until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 5 years | 
| Score of MHU rating scales at 6 months postoperative |  | on 6 months postoperative | 
| overall survival |  | From date of operation until the date of death from any cause, assessed up to 5 years | 
| progression-free survival |  | From date of operation until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years | 
| Score of C-30 life quality rating scales at 6 months postoperative |  | on 6 months postoperative | 
| Score of CX-24 life quality rating scales at 6 months postoperative |  | on 6 months postoperative |