The Value of Uterine Artery Occlusion in Laparoscopic Myomectomy
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ClinicalTrials.gov Identifier: NCT05994560 |
Recruitment Status :
Completed
First Posted : August 16, 2023
Last Update Posted : August 16, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uterine Myomectomy | Other: With temporary occlusion | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | randomized clinical tria |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Valor de la oclusión Temporal de Las Arterias Uterinas en la miomectomía Por Laparoscopia |
Actual Study Start Date : | March 2, 2020 |
Actual Primary Completion Date : | December 21, 2022 |
Actual Study Completion Date : | December 21, 2022 |
Arm | Intervention/treatment |
---|---|
without temporary occlusion
Without temporary occlusion: No occlusion of uterine or útero-ovarian ligaments during laparoscopy myomectomy
|
Other: With temporary occlusion
at the time of surgery the randomization table was consulted and if it was in the occlusion arm was performed |
Active Comparator: With temporary occlusion
Temporary occlusion of the uterine arteries and utero-ovarian ligaments during laparoscopic myomectomy
|
Other: With temporary occlusion
at the time of surgery the randomization table was consulted and if it was in the occlusion arm was performed |
- 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.
- 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).
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05994560
Spain | |
Enrique Moratalla Bartolomé | |
Madrid, Spain, 28029 |
Documents provided by enrique moratalla bartolome, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
Responsible Party: | enrique moratalla bartolome, Principal Investigator, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
ClinicalTrials.gov Identifier: | NCT05994560 |
Other Study ID Numbers: |
324/19 |
First Posted: | August 16, 2023 Key Record Dates |
Last Update Posted: | August 16, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
myomectomy temporary occlusion uerine arteries |