Combined Vaginal Misoprostol and Perivascular Vasopressin
Condition: Leiomyoma; Laparoscopy; Uterine Myomectomy
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Standard; Standard-vaginal misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): 20 units diluted in 100mL of Normal Saline injected laparoscopic needle; 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
Other intervention name(s): Perivascular vasopresssin; perivascular vasopresssin-vaginal misprostol
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Robot-assisted; Laparoscopic; vasopressin; misoprostol; blood loss