The Value of Uterine Artery Occlusion in Laparoscopic Myomectomy

• ClinicalTrials.gov Identifier: NCT05994560
• Recruitment Status: Completed
• First Posted: August 16, 2023
• Last Update Posted: August 16, 2023
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Information provided by (Responsible Party): enrique moratalla bartolome, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Tracking Information

• First Submitted Date: July 20, 2023
• First Posted Date: August 16, 2023
• Last Update Posted Date: August 16, 2023
• Actual Study Start Date: March 2, 2020
• Actual Primary Completion Date: December 21, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 8, 2023)

Blood loss during surgery [ Time Frame: during the time of the surgery ]

The estimated intraoperative blood loss was calculated by measuring the amount of aspirated fluid at the end of the procedure minus the amount of fluid used for irrigation.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 8, 2023)

• To compare the surgical time of each technique [ Time Frame: during surgery ]
  Time was recorded from the first skin incision to the last suture (minutes).
• Length of hospital stay [ Time Frame: until 1 week ]
  Days of hospital admission prior to discharge counting from the day of the intervention.
• Difference in pre and postoperative hemoglobin levels (Hemoglobin loss) [ Time Frame: up to 24 hours after surgery ]
  Preoperative hemoglobin was obtained within 24 hours before surgery, and postoperative hemoglobin was collected on postoperative day 1. Hemoglobin loss expressed in g/dL (grams per deciliter) was obtained from comparing hemoglobine pre and postoperative (before and after surgery).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Value of Uterine Artery Occlusion in Laparoscopic Myomectomy
• Official Title: Valor de la oclusión Temporal de Las Arterias Uterinas en la miomectomía Por Laparoscopia
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

randomized clinical tria

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Uterine Myomectomy

Intervention

Other: With temporary occlusion

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

Study Arms

• without temporary occlusion
  Without temporary occlusion: No occlusion of uterine or útero-ovarian ligaments during laparoscopy myomectomy
  Intervention: Other: With temporary occlusion
• Active Comparator: With temporary occlusion
  Temporary occlusion of the uterine arteries and utero-ovarian ligaments during laparoscopic myomectomy
  Intervention: Other: With temporary occlusion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 8, 2023): 80
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 21, 2022
• Actual Primary Completion Date: December 21, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05994560
• Other Study ID Numbers: 324/19
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: enrique moratalla bartolome, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Original Responsible Party: Same as current
• Current Study Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Verification Date: August 2023