NCT01886508

A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: Female
• Age: 17 Years – 60 Years
• Healthy volunteers: Not accepted

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

• Cervical Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-12-01
• Completion: 2020-12-01
• First posted: 2013-06-26
• Last updated: 2013-07-22

Locations

1 site across 1 country: China