A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
NCT01886508 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2013-07-22
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.
Conditions
Interventions
- PROCEDURE
-
Nerve-spring radical hysterectomy
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.
- PROCEDURE
-
radical hysterectomy
Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.
Sponsors & Collaborators
-
Tumor Hospital of Xin Jiang Medical University,China
collaborator UNKNOWN -
Gui Yang Maternal and Child Health Hospital,China
collaborator UNKNOWN -
The 152nd Hospital of chinese People's Liberation Army
collaborator UNKNOWN -
Nanfang Hospital, Southern Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 17 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2017-12-31
- Completion
- 2020-12-31
Countries
- China
Study Locations
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