Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer

October 12, 2016 updated by: Shanghai Gynecologic Oncology Group

A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study

The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the rate of postvoid residual urine volume (PVR) <50ml on postoperative day 4 in patients with stage IB1 and IIA1 cervix cancer underwent complete nerve-sparing type C1 radical hysterectomy.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

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
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Zhongshan Hospital

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age >=18 years to <= 70 years.
  • Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix.
  • Stage IIA1, or IB1 disease.
  • Karnofsky performance status >70.
  • Patients who comply with follow-up.
  • With written informed consent.

Exclusion Criteria:

  • Age>70
  • History of lower urinary tract damage or surgery.
  • With abnormal urodynamic study results.
  • Karnofsky performance status <70.
  • Patients who have uncontrolled psychological disorders.
  • Unwilling to or unable to comply with protocol.
  • Prior treatment with pelvic radiotherapy

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerve-Sparing Radical Hysterectomy (NSRH)
Type C1 Hysterectomy
Procedure: Nerve-Sparing Radical Hysterectomy
Type C1 NSRH Removal indwelling catheter on day 4 after surgery
Other Names:
  • Fully Pelvic-Nerve Plexus Preserved

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with fully pelvic nerve plexus preserved
Time Frame: up to 30 days
Proportion of patients who had a postvoid residual urine volume (PVR) under 50ml at postoperative day 4
up to 30 days
Proportion of patients removing indwelling catheter
Time Frame: up to 30 days
up to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of 36-month local control
Time Frame: up to 36 months
up to 36 months

Collaborators and Investigators

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

Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zsfdu-obgyn-003

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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