The Value of Uterine Artery Occlusion in Laparoscopic Myomectomy

NCT ID: NCT05994560

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2022-12-21

Brief 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.

Detailed 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.

Conditions

Uterine Myomectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

without temporary occlusion

Without temporary occlusion: No occlusion of uterine or útero-ovarian ligaments during laparoscopy myomectomy

Group Type: OTHER

With temporary occlusion

Intervention Type: OTHER

at the time of surgery the randomization table was consulted and if it was in the occlusion arm was performed

With temporary occlusion

Temporary occlusion of the uterine arteries and utero-ovarian ligaments during laparoscopic myomectomy

Group Type: ACTIVE_COMPARATOR

With temporary occlusion

Intervention Type: OTHER

at the time of surgery the randomization table was consulted and if it was in the occlusion arm was performed

Interventions

With temporary occlusion

at the time of surgery the randomization table was consulted and if it was in the occlusion arm was performed

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with uterine fibroids requiring surgical treatment via laparoscopy and with a desire to preserve the uterus.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

enrique moratalla bartolome

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Enrique Moratalla Bartolomé

Madrid, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

324/19

Identifier Type: -

Identifier Source: org_study_id