The Value of Uterine Artery Occlusion in Laparoscopic Myomectomy
Condition: Uterine Myomectomy
Study type: Interventional

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.
    

Intervention name(s): With temporary occlusion
Intervention type(s): Other
Intervention description(s): at the time of surgery the randomization table was consulted and if it was in the occlusion arm was performed
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: randomized clinical tria
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myomectomy; temporary occlusion; uerine arteries