Vessel Occlusion for Uterine Fibroids
(Myo-Bleed Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if using temporary clamps on blood vessels during fibroid removal surgery can reduce blood loss. It compares two groups: one with clamps and one without. Women undergoing minimally invasive surgery for fibroids, whether a single large one or multiple smaller ones, might be suitable candidates. The goal is to assess if this method makes surgery safer and easier by minimizing bleeding. As an unphased trial, participants contribute to advancing surgical techniques that may enhance safety and outcomes for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this temporary clamping technique is safe for uterine fibroid surgery?
Research has shown that temporarily clamping the blood vessels in the uterus and ovaries is generally safe. Studies have found that this method reduces blood loss during surgery, indicating safety. For example, one study reported no serious complications when using this technique. Patients in these studies did not experience severe side effects from the temporary clamping.
Another study confirmed that using temporary clamps on uterine arteries is both feasible and safe, suggesting the technique is well-tolerated. While individual experiences may vary, current evidence indicates that temporary vessel clamping safely manages blood loss during surgery.12345Why are researchers excited about this trial?
Researchers are excited about the trial for temporary clamping of uterine and ovarian vessels to treat uterine fibroids because this method offers a novel alternative to current surgical options. Unlike standard treatments like hysterectomy or myomectomy, which permanently alter the uterus, this technique temporarily blocks blood flow to the fibroids, potentially reducing their size without surgery. This approach is less invasive, aiming to preserve the uterus and possibly enhance recovery times and fertility outcomes for patients.
What evidence suggests that temporary clamping of uterine and ovarian vessels is effective for reducing blood loss during myomectomy?
This trial will compare the use of temporary vessel clamps with no clamps during surgery for uterine fibroids. Research has shown that using temporary clamps on blood vessels in the uterus and ovaries during surgery can significantly reduce blood loss. One study found that temporary blocking of the uterine artery cut blood loss in half, reducing it from an average of 150 ml to about 75 ml. Other studies have confirmed that this technique is safe and effectively reduces the need for blood transfusions. These clamps temporarily stop blood flow to the area, making the surgery less bloody. Overall, temporary clamping appears to be a promising way to manage blood loss during the surgical removal of fibroids (myomectomy).46789
Are You a Good Fit for This Trial?
This trial is for people having minimally invasive surgery to remove uterine fibroids, either a single large fibroid (5 cm or bigger) or at least five fibroids. Participants must be eligible for this type of surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo minimally invasive myomectomy with or without temporary bilateral uterine and utero-ovarian artery occlusion using laparoscopic clamps
Follow-up
Participants are monitored for safety and effectiveness after the surgical procedure
What Are the Treatments Tested in This Trial?
Interventions
- Temporary clamping of uterine and ovarian vessels
Trial Overview
The study compares two surgical methods: one uses temporary clamps to block blood flow in the uterine and ovarian vessels during myomectomy, while the other does not use these clamps. The goal is to see if clamping reduces blood loss.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Use of temporary laparoscopic vessel clamps on uterine and ovarian vessels
No use of vessel clamps
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Citations
The effect of temporary uterine artery ligation on laparoscopic ...
Results. The intraoperative blood loss volume was decreased by approximately half with the addition of temporary uterine artery ligation (75.1 ± 73.6 ml vs.
Use of a microsurgical vascular clip system for temporary ...
The goal of this study was to examine the safety, feasibility, and effectiveness of the use of a microsurgical temporary vascular clip system to facilitate the ...
Surgical impact of bilateral transient occlusion of uterine ...
We conclude that temporary clamping of bilateral uterine arteries prior to laparoscopic myomectomy is a safe intervention that reduces blood loss without ...
Surgical outcomes after uterine artery occlusion at the time ...
Uterine artery occlusion at myomectomy is associated with decreased surgical blood loss and transfusion rate compared with control patients.
temporary uterine artery cross-clamping for
The aim of this study was to compare various surgical strategies for managing large sub-mucosal uterine fibroids at reproductive age, and to ...
Surgical impact of bilateral transient occlusion of uterine and ...
The aim of this study is to compare the difference in intraoperative blood loss and operative time when performing bilateral temporary clamping ...
The impact of bilateral transient occlusion of uterine and ...
Temporary bilateral clamping of the uterine and utero-ovarian arteries during laparoscopic myomectomy has been linked to decreased intraoperative blood loss ...
Temporary uterine artery occlusion for treatment of ...
We report the successful treatment of a 43-year-old woman with menorrhagia and multiple uterine fibroids by temporary uterine artery occlusion. Using a Doppler- ...
AJOG Surgeons Corner: Vaginal Clamping of Uterine ...
(A) Clamping the lateral vaginal fornix without uterine traction results only in cervical compression, without reaching the uterine artery.
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