Blocking the descending branch of uterine artery in cervical conization
| ISRCTN | ISRCTN50443832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50443832 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/09/2013
- Registration date
- 15/10/2013
- Last edited
- 16/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Obstetrics and Gynecology
Shengjing Hospital of China Medical University
36 Sanhao Street
Shenyang
110004
China
Study information
| Study design | Prospective randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Blocking the descending branch of uterine artery in cervical conization: a randomized controlled trial |
| Study objectives | 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(s) | Approved by Ethics Committee of Shengjing Hospital of China Medical University |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2013 |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/11/2013 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- China
Study participating centre
110004
China
Sponsor information
Hospital/treatment centre
36 Sanhao Street
Shenyang
110004
China
"ROR" |
https://ror.org/0202bj006 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
