Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brigham and Women's Hospital
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
North Shore Medical Center
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Jon I. Einarsson, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01393704
First received: July 11, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Blood Loss, Surgical
Drug: Vasopressin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Estimating blood loss at the end of myomectomy [ Time Frame: 5 minutes post-operatively ] [ Designated as safety issue: Yes ]
    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].


Secondary Outcome Measures:
  • Peri-operative complications [ Time Frame: 8 weeks postoperatively ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Time from incision to end of surgery


Estimated Enrollment: 152
Study Start Date: July 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Pitressin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393704

Contacts
Contact: Jon I Einarsson, MD, MPH. 617 525 8582 Jeinarsson@partners.org
Contact: Sarah L Cohen, MD 617 525 8582 scohen20@partners.org

Locations
United States, Massachusetts
Brigham&Women's hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jon I Einarsson, MD.MPH.    617-525-8582    jeinarsson@partners.org   
Contact: Sarah L Cohen, MD    617 525 8582    scohen20@partners.org   
Principal Investigator: Jon l Einarsson, MD,MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
North Shore Medical Center
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Jon I Einarsson, MD,MPH. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Jon I. Einarsson, Chief, Division of Minimally Invasive Gynecology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01393704     History of Changes
Other Study ID Numbers: 2011-P-000264/1
Study First Received: July 11, 2011
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
myomectomy
vasopressin
blood loss

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014