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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Cervical Cancer

Treatments: Procedure: radical hysterectomy; Procedure: Nerve-spring radical hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01886508

NCT00270426

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 17 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

240 participants in 2 patient groups

NSRH

Experimental group

Description:

patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)

Treatment:

Procedure: Nerve-spring radical hysterectomy

RH

Active Comparator group

Description:

patients in Arm RH undergo radical hysterectomy (RH)

Treatment:

Procedure: radical hysterectomy