Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05994560 |
| Other study ID # |
324/19 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2020 |
| Est. completion date |
December 21, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to determine whether patients undergoing laparoscopic
myomectomy with temporary occlusion of the uterine arteries and utero-ovarian ligaments using
clips experience a decrease in blood loss during surgery compared to patients who undergo
laparoscopic myomectomy without clips.
Description:
Introduction:
Uterine fibroids are the most common benign tumors originating in the smooth muscle of the
female genital tract. They occur in approximately 70% of women of middle age. Often, they
cause abnormal uterine bleeding, pain, pelvic pressure, urinary and intestinal symptoms,
and/or pregnancy complications. However, many fibroids are small and asymptomatic. About 25%
of white women and 50% of black women will develop symptomatic fibroids. Fibroids are more
common among overweight or obese women. Potential protective factors for fibroid occurrence
are pregnancies and smoking, with a possible causal relationship, although the exact
mechanism is not clear.
The treatment for women with uterine fibroids should be individualized based on their
symptoms, size and location of fibroids, age, the need and desire to preserve fertility or
the uterus, the availability of therapy, and the surgeon's experience. While hysterectomy is
the definitive surgical treatment for symptomatic fibroids in women who do not wish to
preserve fertility or their uterus, myomectomy is the treatment of choice for those with
unfulfilled reproductive desires or a clear desire to keep their uterus and who are not
suitable candidates for medical treatment.
The surgical planning for myomectomy should be based on the location, size, and number of
fibroids, aided by appropriate imaging tests such as high-resolution ultrasound or magnetic
resonance imaging (MRI).
Justification of the Study:
Intraoperative bleeding is one of the most frequent complications of laparoscopic myomectomy
and may sometimes require transfusion. Therefore, methods that could reduce bleeding during
surgery have been proposed, such as temporary occlusion of the uterine arteries and
utero-ovarian ligaments. However, the efficacy and safety of this technique for use during
laparoscopic myomectomy have not been clearly investigated.
Research Hypothesis:
The study aims to identify the efficacy of temporary occlusion of the uterine arteries during
laparoscopic myomectomy.
Objectives:
Primary Objective:
- To compare the hemoglobin loss in g/dL (grams per deciliter) before and after surgery and
intraoperative blood aspirate in milliliters between two groups of patients with symptomatic
fibroids undergoing laparoscopic surgery, one with temporary occlusion of uterine arteries
and utero-ovarian ligaments using clips and the other without such occlusion.
Secondary Objectives:
- To compare the surgical time of each technique.
- To compare the need for transfusion between both groups.
- To compare the improvement in symptoms for which the patients undergo surgery.
- To compare the length of hospital stay in each group.
- To compare possible complications of each technique.
Methodology:
Design:
A prospective randomized longitudinal study.
Study Subjects:
Patients with symptomatic fibroids requiring laparoscopic surgery as treatment, from the
Gynecology Service of Hospital Ramón y Cajal and the HM Hospital, will be recruited. They
will be randomized into two groups using simple random sampling. Patients will be given
informed consent to participate in the study. The diagnosis of fibroids will be made through
abdominal and/or transvaginal gynecological ultrasound and/or MRI.
Inclusion Criteria:
- Patients with uterine fibroids requiring surgical treatment via laparoscopy and with a
desire to preserve the uterus.
Exclusion Criteria:
- Patients who do not meet the inclusion criteria.
- Women with symptomatic fibroids who are not candidates for laparoscopic surgery and/or
have no desire to preserve the uterus.
- Patients for whom technical placement of clips during the intervention is not possible.
Main Variables:
- Preoperative and postoperative hemoglobin levels measured in g/dL.
- Intraoperative blood aspirate in milliliters.
- Surgical time.
- Need for transfusion.
- Improvement in symptoms.
- Length of hospital stay.
- Complications.
Data Collection:
The data will be collected from the patients' medical records and entered into a database
using the SPSS software (version 23.0).
Ethical Aspects:
The study will follow the ethical principles laid out in the Declaration of Helsinki and Good
Clinical Practice guidelines. Confidentiality of patient data will be maintained, and
patients will provide informed consent to participate in the study.
Policy of Publications:
The study results will be published in scientific journals and medical conferences, subject
to approval from the investigator and the Thesis Directors. The results will also be used as
the basis for the investigator's doctoral thesis.
