Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
Condition: Blood Loss, Surgical
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to compare blood loss at the time of laparoscopic or
      robotically-assisted laparoscopic myomectomy when using different amounts of dilute
      vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus.
      Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic
      surgery; although very little is know about the optimal dosage and administration.

      The investigators plan to perform a randomized clinical trial on patients scheduled for
      minimally invasive myomectomy. All patients will get the same overall amount of vasopressin.
      Patients will be assigned by chance to one of two groups: one group will receive higher
      volume of a more dilute vasopressin solution. The other group will receive a lower volume of
      a more concentrated solution. The investigators will collect information on operative blood
      loss and complications related to surgery.
    

Detailed description: 
      All surgeons who enroll patients into our study are experienced laparoscopic surgeons who
      have performed at least 100 advanced laparoscopic procedures including hysterectomies and
      myomectomies. Briefly, our laparoscopic myomectomy technique is as follows: After gaining
      peritoneal access and placing visual and operative trocars, the surgical site is inspected
      carefully and fibroid locations identified. After informing the anesthesia team that
      vasopressin (from pharmaceutical company American Regent 20 units/ml) is about to be
      injected, the uterus is infiltrated with vasopressin.

      Patients will be randomized one of two treatment groups pre-operatively on the day of
      surgery:

        1. One arm will receive injection of 200 ml total of the 0.05 units/ml dilute vasopressin
           solution (total 10 units Vasopressin used, dilution of 20 units vasopressin in 400 ml of
           normal saline).

        2. The second arm will receive injection of 30 ml total of the 0.3 units/ml dilute
           vasopressin solution (total 10 units Vasopressin used, dilution of 20 units Vasopressin
           in 60 mL of Normal Saline).

      The procedure is done according to surgeon preference using various energy modalities such as
      monopolar or Harmonic Scalpel® (Ethicon Endo-Surgery, Cincinnati OH), for making the incision
      in the uterus. The fibroid is then removed from the uterus and examined. The incision is then
      closed in several layers with laparoscopic standard suturing technique, and hysterotomy site
      is generally covered with an adhesion barrier (Gynecare Interceed® (Ethicon Women's Health
      and Urology, Somerville NJ) or Seprafilm® slurry (Genzyme Biosurgery, Framingham MA)).

      Blood Samples:

      As per routine, preoperative blood samples to assess hematocrit levels will be taken no
      greater than 2 weeks prior to surgical date; if no preoperative laboratory studies have been
      obtained a sample will be drawn on the day of surgery. Postoperative blood samples to assess
      hematocrit will be taken no sooner than 4 hours after surgery for patients who are discharged
      the same day; for patients who are monitored overnight in hospital, the lab will be drawn on
      postoperative day #1.

      Follow-up:

      Patients will be followed for 8 weeks after surgery to assess for occurrence of any
      postoperative complication. A member of the team (health care worker such as research
      assistant who has been trained in HIPPA procedures) will be in charge of abstracting data
      from the medical records and entering this information into a study database.
    

Intervention name(s): Vasopressin
Intervention type(s): Drug
Intervention description(s): Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.
Other intervention name(s): Pitressin
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: myomectomy; vasopressin; blood loss