Clinical Trial: Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

Brief 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 Summary:

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:

  • Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage [ Time Frame: 5 minutes post-operatively ]
    To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Pre and post-operative hematocrit change (%) was one of these measurement methods.
  • Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss [ Time Frame: 5 minutes post-operatively ]
    To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome: Subjective surgeon's estimate of blood loss (ml) was one measurement method.
  • Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation [ Time Frame: 5 minutes post-operatively ]
    To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Objective calculation of blood loss via the measurement of suction canister fluid (ml) was one of these. The calculation for estimated blood loss will be as follows: EBL = [total suction canister volume] - [volume of irrigation used] - [volume of vasopressin solution injected /2].


    • Original Primary Outcome: Estimating blood loss at the end of myomectomy [ Time Frame: 5 minutes post-operatively ]

    To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss. Three parameters will be collected to assess this outcome: Hematocrit change (%) pre and post-operatively; subjective surgeon's estimate of blood loss; objective calculation of blood loss: Suction canister fluid will be measured. The calculation for estimated blood loss will be as follows: EBL = [total suction canister volume] - [volume of irrigation used] - [volume of vasopressin solution injected /2].


    Current Secondary Outcome:

    • Number of Participants With Peri-operative Complications [ Time Frame: 8 weeks postoperatively ]
      Intra or post-operative complications (including but not limited to need for blood transfusion or adverse effect related to Vasopressin).
    • Total Operation Time [ Time Frame: 5 minutes postoperatively ]
      Time from incision to end of surgery


    Original Secondary Outcome:

    • Peri-operative complications [ Time Frame: 8 weeks postoperatively ]
      Intra or post-operative complications (including but not limited to need for blood transfusion or adverse effect related to Vasopressin).
    • Total Operation Time [ Time Frame: 5 minutes postoperatively ]
      Time from incision to end of surgery


    Information By: Brigham and Women's Hospital

    Dates:
    Date Received: July 11, 2011
    Date Started: July 2011
    Date Completion:
    Last Updated: April 7, 2017
    Last Verified: April 2017