Combined Vaginal Misoprostol and Perivascular Vasopressin

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy

Conditions
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Leiomyoma, Laparoscopy, Uterine Myomectomy

Intervention / Treatment
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* Drug: Standard
* Drug: Standard-vaginal misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy. Exclusion Criteria: History of adverse reaction or allergy to Vasopressin. History of adverse reaction or allergy to Misoprostol. Medical contraindication to use of Vasopressin or Misoprostol Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue. 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. 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. Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. | Drug: Standard-vaginal misoprostol<br>* 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg<br>* Other names: perivascular vasopresssin-vaginal misprostol;|
| Experimental: Standard-Vaginal Misoprostol<br>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 . | Drug: Standard<br>* 20 units diluted in 100mL of Normal Saline injected laparoscopic needle<br>* Other names: Perivascular vasopresssin;Drug: Standard-vaginal misoprostol<br>* 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg<br>* Other names: perivascular vasopresssin-vaginal misprostol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Blood Loss | The amount of blood loss during robotic assisted laparoscopic myomectomy | 0 hours up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Operative Time | Total time of the robotic assisted laparoscopic myomectomy | 0 hours up to 24 hours | 
| Side Effects | Side Effect profile for Misoprostol Use | 0 hours up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot-assisted, Laparoscopic, vasopressin, misoprostol, blood loss