Laparoscopy, Leiomyoma, Uterine Myomectomy
Conditions
Keywords
Robot-assisted, Laparoscopic, vasopressin, misoprostol, blood loss
Brief summary
Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.
Detailed description
Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough to warrant treatment in 20-50% of reproductive age women, including abnormal uterine bleeding, pelvic pain, and infertility. While hysterectomy with removal of the uterus is standard of care for symptomatic uterine fibroids, women desiring future child bearing require removal of the fibroids alone via uterine myomectomy, with re-construction of the uterus after removal. A well established risk to such a procedure is the operative blood loss, which can be quite significant due to the increased blood supply fibroids accumulate. Several interventions have been looked at as potential methods to help decrease operative blood loss. Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. A known potential side effect of vasopressin is cardiovascular compromise, which can be catastrophic if vasopressin is inadvertently injected into the large vessels of the uterus. This limits the amount that can be safely used in surgery. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus. While Vasopressin is more commonly used during surgery, the associated potential risks limit the amount that can be safely administered. However, the addition Misoprostol, with a relatively safe side effect profile, can further improve control of the blood supply and decrease operative blood loss. Misoprostol can be administered orally, sublingually, or as vaginal or rectal suppositories. While the systemic absorption of vaginal Misoprostol is slower in onset than the oral or sublingual routes, the effect is maintained for a longer period of time, and is more conducive to use during laparoscopic or robotic assisted myomectomies given the prolonged operative time associated with minimally invasive techniques when compared to traditional open approaches. This study aims to determine whether using vaginal Misoprostol in combination with Vasopressin is more effective at decreasing operative blood loss during robotic assisted laparoscopic myomectomy than Vasopressin alone.
Interventions
DRUGStandard
20 units diluted in 100mL of Normal Saline injected laparoscopic needle
DRUGStandard-vaginal misoprostol
20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
Sponsors
Antonios Likourezos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy.
Exclusion criteria
1. History of adverse reaction or allergy to Vasopressin. 2. History of adverse reaction or allergy to Misoprostol. 3. Medical contraindication to use of Vasopressin or Misoprostol 4. Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue. 5. Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating. 6. Any clinically significant even or condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course. 7. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Levels Difference Between Pre and Post Surgery. | 1 hour | The difference in hemoglobin levels between pre surgery and post surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.
Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg | 42 |
| Standard-Vaginal Misoprostol Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .
Standard: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle
Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg | 32 |
| Total | 74 |
Baseline characteristics
| Characteristic | Standard-Vaginal Misoprostol | Total | Standard |
|---|---|---|---|
| Age, Continuous | 37.10 years STANDARD_DEVIATION 6.8 | 37.14 years STANDARD_DEVIATION 6.5 | 37.17 years STANDARD_DEVIATION 6.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 32 Participants | 74 Participants | 42 Participants |
| Sex: Female, Male Female | 32 Participants | 74 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 32 |
| other Total, other adverse events | 0 / 42 | 0 / 32 |
| serious Total, serious adverse events | 0 / 42 | 0 / 32 |
Outcome results
Primary
Hemoglobin Levels Difference Between Pre and Post Surgery.
The difference in hemoglobin levels between pre surgery and post surgery
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard | Hemoglobin Levels Difference Between Pre and Post Surgery. | 0.76 g/dL | Standard Deviation 0.89 |
| Standard-Vaginal Misoprostol | Hemoglobin Levels Difference Between Pre and Post Surgery. | 0.93 g/dL | Standard Deviation 1.36 |