The Value of Uterine Artery Occlusion in Laparoscopic Myomectomy

NCT05994560 | Completed DMC

• 1 other identifier: 324/19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Myomectomy

Keywords

myomectomy; temporary occlusion; uerine arteries

Outcome Measures

Primary Outcomes (1)

• Blood loss during 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.

  during the time of the surgery

Secondary Outcomes (3)

• To compare the surgical time of each technique

  during surgery

• Length of hospital stay

  until 1 week

• Difference in pre and postoperative hemoglobin levels (Hemoglobin loss)

  up to 24 hours after surgery

Study Arms (2)

without temporary occlusion

OTHER

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

Other: With temporary occlusion

With temporary occlusion

ACTIVE COMPARATOR

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

Other: With temporary occlusion

Interventions

With temporary occlusion OTHER

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

With temporary occlusion; without temporary occlusion

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Enrique Moratalla Bartolomé

Madrid, 28029, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized clinical tria

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 16, 2023
• Study Start: March 2, 2020
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)