A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
July 19, 2013 updated by: Nanfang Hospital of Southern Medical University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Southern Medical University, China
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NSRH
patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)
|
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.
|
|
Active Comparator: RH
patients in Arm RH undergo radical hysterectomy (RH)
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Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
maximum flow rate measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
|
on 6 months postoperative
|
|
residual volume measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
|
on 6 months postoperative
|
|
maximum vesical compliace measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
|
on 6 months postoperative
|
|
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
|
on 6 months postoperative
|
|
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
|
on 6 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time (days) to residual urine volume less than 100ml postoperative
Time Frame: from operation to residual urine volume less than 100ml, assessed up to 30 days
|
from operation to residual urine volume less than 100ml, assessed up to 30 days
|
|
time (hours) to break wind postoperative
Time Frame: from operation to have the first break wind, assessed up to 72 hours
|
from operation to have the first break wind, assessed up to 72 hours
|
|
time (hours) to defecation postoperative
Time Frame: from operation to have the first defection, assessed up to 72 hours
|
from operation to have the first defection, assessed up to 72 hours
|
|
Number of participants with adverse events
Time Frame: 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
|
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
Time Frame: on 6 months postoperative
|
on 6 months postoperative
|
|
overall survival
Time Frame: From date of operation until the date of death from any cause, assessed up to 5 years
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From date of operation until the date of death from any cause, assessed up to 5 years
|
|
progression-free survival
Time Frame: From date of operation until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years
|
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
Time Frame: on 6 months postoperative
|
on 6 months postoperative
|
|
Score of CX-24 life quality rating scales at 6 months postoperative
Time Frame: on 6 months postoperative
|
on 6 months postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
September 25, 2012
First Submitted That Met QC Criteria
June 23, 2013
First Posted (Estimate)
June 26, 2013
Study Record Updates
Last Update Posted (Estimate)
July 22, 2013
Last Update Submitted That Met QC Criteria
July 19, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCT00270426
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.