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

Not Applicable

• Conditions: Cervical Cancer
• Interventions: Procedure: Nerve-spring radical hysterectomy; Procedure: radical hysterectomy

• Registration Number: NCT01886508
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-25
• Status Verified: 2013-05
• Study First Submitted QC: 2013-06-23
• Study First Posted: 2013-06-26
• Study Start: 2013-07
• Last Update Submitted: 2013-07-19
• Last Update Posted: 2013-07-22
• Primary Completion: 2017-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1. 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
2. Possible to radical hysterectomy or nerve-spring radical hysterectomy
3. Age: 17 to 60 years
4. No complication during operation
5. Written informed consent

Exclusion Criteria

1. patients who underwent radiotherapy
2. Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma
3. Patients who have uncontrolled diabetes or uncontrolled hypertension
4. patients with neurogenic bladder dysfunction
5. patients with uterine prolapse
6. Patients with psychiatric illness
7. Patients who have active infection
8. Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months
9. Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSRH	Nerve-spring radical hysterectomy	patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)
RH	radical hysterectomy	patients in Arm RH undergo radical hysterectomy (RH)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Southern Medical University, China; 🇨🇳 Guangzhou, Guangdong, China