Clinical trial NCT01886508: A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Tumor Hospital of Xin Jiang Medical University,China
name: Gui Yang Maternal and Child Health Hospital,China
name: The 152nd Hospital of chinese People's Liberation Army
First posted: 2013-06-26
Enrollment: 240
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: maximum flow rate measured by Urodynamic at 6 months postoperative
timeFrame: on 6 months postoperative
measure: residual volume measured by Urodynamic at 6 months postoperative
timeFrame: on 6 months postoperative
measure: maximum vesical compliace measured by Urodynamic at 6 months postoperative
timeFrame: on 6 months postoperative
measure: cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
timeFrame: on 6 months postoperative
measure: maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
timeFrame: on 6 months postoperative
Secondary outcomes:
measure: Time (days) to residual urine volume less than 100ml postoperative
timeFrame: from operation to residual urine volume less than 100ml, assessed up to 30 days
measure: time (hours) to break wind postoperative
timeFrame: from operation to have the first break wind, assessed up to 72 hours
measure: time (hours) to defecation postoperative
timeFrame: from operation to have the first defection, assessed up to 72 hours
measure: Number of participants with adverse events
timeFrame: 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
measure: Score of MHU rating scales at 6 months postoperative
timeFrame: on 6 months postoperative
measure: overall survival
timeFrame: From date of operation until the date of death from any cause, assessed up to 5 years
measure: progression-free survival
timeFrame: From date of operation until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years
measure: Score of C-30 life quality rating scales at 6 months postoperative
timeFrame: on 6 months postoperative
measure: Score of CX-24 life quality rating scales at 6 months postoperative
timeFrame: on 6 months postoperative
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University, China
state: Guangdong
Study officials:
References: