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

July 19, 2013 updated by: Nanfang Hospital of Southern Medical University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSRH
patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)
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.
Active Comparator: RH
patients in Arm RH undergo radical hysterectomy (RH)
Procedure: radical hysterectomy
Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum flow rate measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
residual volume measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
maximum vesical compliace measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
on 6 months postoperative
Score of CX-24 life quality rating scales at 6 months postoperative
Time Frame: on 6 months postoperative
on 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Tumor Hospital of Xin Jiang Medical University,China
Gui Yang Maternal and Child Health Hospital,China
The 152nd Hospital of chinese People's Liberation Army

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

June 23, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

July 22, 2013

Last Update Submitted That Met QC Criteria

July 19, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT00270426

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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