Myoma, Surgery
Conditions
Keywords
myoma, blood loss
Brief summary
This study hypothesizes that temporary bilateral uterine and utero-ovarian artery occlusion with laparoscopic clamps at time of minimally invasive myomectomy will lead to a decreased blood loss at time of myomectomy compared to minimally invasive myomectomy without temporary occlusion.
Detailed description
Background: Leiomyomas are the most common benign tumor of the uterus and affect approximately 70-80% of the population with a uterus . Patients who opt to undergo treatment for a fibroid uterus have a variety of options including medical management, embolization, or surgical management; Historically surgical management involved hysterectomy; however, myomectomy has become more popular as a uterine sparing option. Current data supports that minimally invasive myomectomy is associated with lower morbidity and blood loss than traditional abdominal surgery. With advances in Minimally invasive myomectomy (MIS). There continues to be interest in methods to better improve intraoperative and postoperative outcomes. There is currently support for universal use of intramural vasopressin at time of myomectomy and a growing body of evidence to support temporary bilateral occlusion of the uterine and/or uteroovarian arteries at time of myomectomy to decrease blood loss. High myoma burden is associated with an increased blood loss at time of surgical management. Previous studies assessing the utility in temporary occlusion of the uterine and/or utero-ovarian vessels have not specifically evaluated the impact on high myoma burden individuals. As higher myoma burden is addressed in a minimally invasive fashion, it is important to specifically evaluate techniques to optimize these procedures. This study will specifically evaluate the effect of temporary bilateral uterine artery and utero-ovarian occlusion with laparoscopic clamps at the time of minimally invasive myomectomy.
Interventions
OTHERTemporary clamping of uterine and ovarian vessels
Surgeon will temporarily clamp uterine and ovarian vessels.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient undergoing minimally invasive myomectomy with either a single intramural or Submucosal fibroid =/\>5cm or * Patients undergoing minimally invasive Myomectomy with =/\> 5 fibroids
Exclusion criteria
* Pregnancy, * Age \<18yo, * Patients undergoing concomitant surgery such as endometriosis surgery, * Suspected malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated blood loss | Intraoperative (during surgery, which is < 24 hours) | Estimated blood loss during the surgery between groups, calculated by suction prior to irrigation. |
Countries
United States
Contacts
CONTACTRanda Jalloul, MD
Outcome results
None listed