Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Drug: Vasopressin

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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham&Women's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• The inclusion criteria for our study include all women who are candidates for a laparoscopic or robotic-assisted laparoscopic myomectomy and are willing to accept randomization.
• The exclusion criteria: for our study include: suspected malignancy or contraindication to morcellation of uterine tissue, history of adverse reaction or allergy to vasopressin, and active cardiovascular or pulmonary disease that would indicate a contradiction to use of vasopressin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Volume Dilute Vasopressin; 20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).	Drug: Vasopressin; Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.; Other Names: Pitressin
Active Comparator: Low volume dilute vasopressin; 20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).	Drug: Vasopressin; Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.; Other Names: Pitressin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage	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.	5 minutes post-operatively
Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss	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.	5 minutes post-operatively
Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation	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].	5 minutes post-operatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Cedars-Sinai Medical Center; North Shore Medical Center
• Investigators: Principal Investigator: Jon I Einarsson, MD,MPH., Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: blood loss; vasopressin; myomectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: 2011-P-000264/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No