Results of using laparoscopic (keyhole) surgery to remove large fibroids (noncancerous growth of muscle tissue in the uterus) with temporary clamping of the uterine blood vessels compared to other surgical methods
| ISRCTN | ISRCTN13841888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13841888 |
- Submission date
- 20/01/2023
- Registration date
- 25/01/2023
- Last edited
- 23/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
A fibroid is a noncancerous (benign) growth of muscle tissue in the uterus. They are also known as "leiomyomas" or "myomas." They can vary in size and can be found either inside the uterus, on the outer surface of the uterus, or within the uterine wall. Some women with fibroids do not experience any symptoms, while others may experience heavy menstrual bleeding, pelvic pain and pressure, or difficulty getting pregnant.
The aim of the study is to test if different surgical techniques for fibroid removal can improve the results of infertility treatment in women of reproductive age with uterine fibroids.
Who can participate?
Women aged 25-30 years, with primary infertility and fibroids, who are planning a pregnancy.
What does the study involve?
"Laparoscopic myomectomy" is a type of surgery that uses a thin tube with a camera on the end (laparoscope) to remove fibroids (also known as "leiomyoma nodules") from the uterus. "Temporary cross-clamping of uterine arteries" means that during the surgery, the blood flow to the uterus is temporarily stopped by clamping the arteries that supply blood to the uterus. This is done to control bleeding during the surgery.
Participants are randomly allocated to 4 groups: 1. Laparotomy myomectomy; 2. Laparoscopy without uterine artery cross-clamping; 3. Laparoscopy with uterine artery cross-clamping; 4. Resectoscopy myomectomy. Three months later, the scar was assessed and the condition of the uterine cavity during hysteroscopy. Long-term results were assessed by the number and time of pregnancy and childbirth after the operation.
What are the possible benefits and risks of participating?
The benefits of participation are the opportunity to receive highly specialized medical care and improve health.
Risks - standard surgical and anesthetic risks.
Where is the study run from?
The Institute of Reproductive Medicine (Kazakhstan)
When is the study starting and how long is it expected to run for?
March 2018 to October 2022
Who is funding the study?
The Institute of Reproductive Medicine (Kazakhstan)
Who is the main contact?
Z.E. Barmanasheva, zaurew9@gmail.com
Contact information
Scientific
3-124. Shagabutdinov street
Almaty
050012
Kazakhstan
 ORCID ID |
0000-0002-4827-0005 |
|---|---|
| Phone | +7 7014029691 |
| ingling-freia@mail.ru |
Study information
| Study design | Single-centre interventional not-blunded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43085 PIS.pdf |
| Scientific title | Comparison of reproductive and other outcomes in laparoscopic myomectomy with temporary cross-clamping of uterine arteries for submucosal large leiomyoma nodules with other surgical techniques |
| Study acronym | Sublapec |
| Study objectives | Laparoscopic myomectomy with temporary cross-clamping of uterine arteries is the best method for surgical treatment for submucosal large leiomyoma |
| Ethics approval(s) | Approved 28/11/2022, Ethics Commission of the Kazakhstan Medical University "Higher School of Public Health" (19A Utepov street, Аlmaty, Republic of Kazakhstan, +7(727) 337 80 28; ksph@ksph.kz), ref: 04-09-86719 |
| Health condition(s) or problem(s) studied | Improve treatment outcomes for women with infertility associated with uterine fibroids |
| Intervention | The authors randomized the participants into 4 groups. Each of the participants was given an envelope with the number of the group generated by a computer: 1. Laparotomy myomectomy; 2. Laparoscopy without uterine artery cross-clamping; 3. Laparoscopy with uterine artery cross-clamping; 4. Resectoscopy myomectomy. The main researcher knew about the allocation of the study groups. Three months later, the scar was assessed and the condition of the uterine cavity during hysteroscopy. Long-term results were assessed by the number and time of pregnancy and childbirth after the operation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Hemoglobin level is measured using general blood analysis at the initial visit, before and after the operation. 2. Blood loss is measured using blood control system during the operation. 3. Intrauterine pathology is measured using hysteroscopy 3 months after the operation. |
| Secondary outcome measures | Diagnostic hysteroscopy was performed 3 months after the operation and every 6 months after hysteroscopic control for 2 years. The questions concerned only the following: the onset of spontaneous pregnancy, gestational age and outcome of pregnancy. |
| Overall study start date | 01/03/2018 |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 160 participants, divided into 4 groups of 40 people |
| Total final enrolment | 160 |
| Key inclusion criteria | 1. Age from 25 to 30 years; 2. Presence of one 4–6 cm myoma nodule according to expert ultrasound; 3. Anti-Mullerian hormone (AMH) level not less than 2 ng/ml; 4. Confirmed patency of both uterine tubes; 5. Confirmed absence of other forms of infertility; 6. Primary infertility; 7. Patients planning spontaneous pregnancy |
| Key exclusion criteria | 1. Acute or chronic inflammatory and infectious diseases during exacerbation; 2. Malignant neoplasms; 3. Benign neoplasms of the ovaries and/or uterus; 4. Hemorrhoids of stage 3 or 4; 5. Uncompensated chronic somatic diseases; 6. Thromboses; 7. Hemoglobin level of less than 100 g/l for groups 1;2;4; for group 3 it is less than 90 g/l; 8. Non-compliance with the inclusion criteria. |
| Date of first enrolment | 01/07/2018 |
| Date of final enrolment | 01/07/2022 |
Locations
Countries of recruitment
- Kazakhstan
Study participating centre
Almaty
050009
Kazakhstan
Sponsor information
Hospital/treatment centre
99. Tole bi street
Almaty
050009
Kazakhstan
| Phone | +7 7719343434 |
|---|---|
| info@irm.kz |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 23/01/2023 | No | Yes | ||
| Protocol file | 23/01/2023 | No | No |
Additional files
Editorial Notes
23/01/2023: Trial's existence confirmed by Ethics Commission of the Kazakhstan Medical University "Higher School of Public Health"
