Condition category
Urological and Genital Diseases
Date applied
15/09/2013
Date assigned
15/10/2013
Last edited
16/10/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical cancer is the third most common gynecological cancer but the stage called Cervical intraepithelial neoplasia (CIN) is curable with resection. Screening tests have become more common and are the main way of preventing cervical cancer. The microscopic examination of cells scraped off the cervical epithelium (Pap smear test) gives important screening information and grades CIN from 1 to 3. The removal of a cone-shaped section of the cervix with a blade (called a cold knife conization) is the main surgical procedure for premalignant lesions of the cervix, especially for those young patients who wish to have children later.
Bleeding is an important aspect of the procedure. The descending branch of the uterine artery is the main blood supply for the cervix. Conization normally takes about 10-15 minutes, so blocking the descending branch of uterine artery temporarily may be a simple but convenient, effective and safe way of reducing bleeding and facilitating the procedure. This is the aim of the study.

Who can participate?
Our trial aims to recruit about 100 female patients in the Department of Obstetrics and Gynecology of Shengjing Hospital, aged between 18 and 65, who have CIN2 with a large area of lesion or invading the glands, or who have CIN3 and want to have children.

What does the study involve?
The study will involve 100 female patients who will randomly allocated to one of two groups: a control group or an experimental group. The control group will receive conventional cold knife conization only. The experimental group will receive cold knife conization and blocking of the descending branch of uterine artery
During the procedure, we will compare the amount of blood loss in each group. After the operation and at follow-up, we will compare the cure rate, recurrence rate, and the rate of complications (such as abnormal post-operative bleeding, infection, bladder injury, incompetent cervix and cervical stenosis) in each group.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But patients in the experimental group will benefit from the modification of the procedure (less blood loss, shorter operation time and fewer post-operative complications). This may also help standardize cold knife conization.
Risks involve damage to the arterial branches by mistake, leading to bleeding and hematomas and damage to the bladder but measures are in place to minimize such risks.

Where is the study run from?
This study has been set up by the Department of Obstetrics and Gynecology of Shengjing Hospital of China Medical University (China).

When is the study starting and how long is it expected to run for?
The study will start in November 2013 and will run for 8 months, or until the required number of 100 participants have been recruited. The study will continue as we follow up participants’ long-term prognosis and complications.

Who is funding the study?
New Technology Project of Shengjing Hospital of China Medical University (China).

Who is the main contact?
Professor Dan-Bo Wang
wangdbsj@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dan-Bo Wang

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Shengjing Hospital of China Medical University
36 Sanhao Street
Shenyang
110004
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Blocking the descending branch of uterine artery in cervical conization: a randomized controlled trial

Acronym

Study hypothesis

Blocking the descending branch of uterine artery temporarily is an effective measure to reduce bleeding and to facilitate surgery during cold knife conization of the cervix.

Ethics approval

Approved by Ethics Committee of Shengjing Hospital of China Medical University

Study design

Prospective randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cervical intraepithelial neoplasia

Intervention

Blocking the descending branch of uterine artery.The study will involve 100 female patients who will be randomized to either a control group or an experimental group:

1. The control group will receive conventional cold knife conization only.
2. The experimental group will receive cold knife conization and blocking of the descending branch of uterine artery.

Follow-up is required for all participants. Repeat Pap smears, colposcopy and HPV DNA testing are carried out 2 months after the operation. Pap smear and HPV DNA testing are carried out every 6 months for 2 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Hemorrhage during surgery measured by evaluating the volume (ml) of blood loss during procedure

Secondary outcome measures

1. Operation time
2. The cure rate at follow-up
3. The recurrence rate at follow-up
4. The rate of postoperative complications: abnormal post-operative bleeding, infection, bladder injury, incompetent cervix and cervical stenosis

Overall trial start date

01/11/2013

Overall trial end date

01/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All cases that meet the criteria for cold knife conization:
1. Patients who have CIN2 with a large area of lesion or invading the glands
2. Patients who have CIN3 and want to have children

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Patients with contraindications
2. Patients who have previously undergone cervical surgery (which has an impact on the anatomy of the cervix and the ureter)

Recruitment start date

01/11/2013

Recruitment end date

01/07/2014

Locations

Countries of recruitment

China

Trial participating centre

Department of Obstetrics and Gynecology
Shenyang
110004
China

Sponsor information

Organisation

Shengjing Hospital of China Medical University (China)

Sponsor details

36 Sanhao Street
Shenyang
110004
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

New Technology Project of Shengjing Hospital of China Medical University, China

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes