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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
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.
Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.
Southern Medical University, China
Guangzhou, Guangdong, China
maximum flow rate measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
residual volume measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
maximum vesical compliace measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
Time frame: on 6 months postoperative
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
time (hours) to break wind postoperative
Time frame: 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
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
Score of MHU rating scales at 6 months postoperative
Time frame: 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
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
Score of C-30 life quality rating scales at 6 months postoperative
Time frame: on 6 months postoperative
Score of CX-24 life quality rating scales at 6 months postoperative
Time frame: on 6 months postoperative
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