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Trial Title:
A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
NCT ID:
NCT01886508
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Nerve-spring radical hysterectomy
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.
Arm group label:
NSRH
Intervention type:
Procedure
Intervention name:
radical hysterectomy
Description:
Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1
hysterectomy.
Arm group label:
RH
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
17 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Medical University, China
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Contact:
Last name:
Chunlin Chen, M.D.,Ph.D.
Email:
chenchunlinrct@163.com
Investigator:
Last name:
Chenlin Chen, M.D.,Ph.D.
Email:
Principal Investigator
Start date:
July 2013
Completion date:
December 2020
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Tumor Hospital of Xin Jiang Medical University,China
Agency class:
Other
Collaborator:
Agency:
Gui Yang Maternal and Child Health Hospital,China
Agency class:
Other
Collaborator:
Agency:
The 152nd Hospital of chinese People's Liberation Army
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01886508
