Back to resultsA Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nerve-spring radical hysterectomy
radical hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
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
Sites / Locations
- Southern Medical University, China
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NSRH
RH
Arm Description
patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)
patients in Arm RH undergo radical hysterectomy (RH)
Outcomes
Primary Outcome Measures
maximum flow rate measured by Urodynamic at 6 months postoperative
residual volume measured by Urodynamic at 6 months postoperative
maximum vesical compliace measured by Urodynamic at 6 months postoperative
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
Secondary Outcome Measures
Time (days) to residual urine volume less than 100ml postoperative
time (hours) to break wind postoperative
time (hours) to defecation postoperative
Number of participants with adverse events
Score of MHU rating scales at 6 months postoperative
overall survival
progression-free survival
Score of C-30 life quality rating scales at 6 months postoperative
Score of CX-24 life quality rating scales at 6 months postoperative
Full Information
NCT ID
NCT01886508
First Posted
September 25, 2012
Last Updated
July 19, 2013
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Tumor Hospital of Xin Jiang Medical University,China, Gui Yang Maternal and Child Health Hospital,China, The 152nd Hospital of chinese People's Liberation Army
1. Study Identification
Unique Protocol Identification Number
NCT01886508
Brief Title
A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Tumor Hospital of Xin Jiang Medical University,China, Gui Yang Maternal and Child Health Hospital,China, The 152nd Hospital of chinese People's Liberation Army
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NSRH
Arm Type
Experimental
Arm Description
patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)
Arm Title
RH
Arm Type
Active Comparator
Arm Description
patients in Arm RH undergo radical hysterectomy (RH)
Intervention Type
Procedure
Intervention Name(s)
Nerve-spring radical hysterectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
radical hysterectomy
Intervention Description
Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.
Primary Outcome Measure Information:
Title
maximum flow rate measured by Urodynamic at 6 months postoperative
Time Frame
on 6 months postoperative
Title
residual volume measured by Urodynamic at 6 months postoperative
Time Frame
on 6 months postoperative
Title
maximum vesical compliace measured by Urodynamic at 6 months postoperative
Time Frame
on 6 months postoperative
Title
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
Time Frame
on 6 months postoperative
Title
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
Time Frame
on 6 months postoperative
Secondary Outcome Measure Information:
Title
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
Title
time (hours) to break wind postoperative
Time Frame
from operation to have the first break wind, assessed up to 72 hours
Title
time (hours) to defecation postoperative
Time Frame
from operation to have the first defection, assessed up to 72 hours
Title
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
Title
Score of MHU rating scales at 6 months postoperative
Time Frame
on 6 months postoperative
Title
overall survival
Time Frame
From date of operation until the date of death from any cause, assessed up to 5 years
Title
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
Title
Score of C-30 life quality rating scales at 6 months postoperative
Time Frame
on 6 months postoperative
Title
Score of CX-24 life quality rating scales at 6 months postoperative
Time Frame
on 6 months postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenlin Chen, M.D.,Ph.D.
Phone
+8602062787947
Email
chenchunlinrct@163.com
Facility Information:
Facility Name
Southern Medical University, China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunlin Chen, M.D.,Ph.D.
Email
chenchunlinrct@163.com
First Name & Middle Initial & Last Name & Degree
Chenlin Chen, M.D.,Ph.D.
12. IPD Sharing Statement
Learn more about this trial
A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
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