Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 19, 2014
Last verified: September 2014

July 11, 2011
September 19, 2014
July 2011
April 2015   (final data collection date for primary outcome measure)
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].
Same as current
Complete list of historical versions of study NCT01393704 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Blood Loss, Surgical
Drug: Vasopressin
Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.
Other Name: Pitressin
  • 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).
    Intervention: Drug: Vasopressin
  • 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).
    Intervention: Drug: Vasopressin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years to 60 Years
No
Contact: Jon I Einarsson, MD, MPH. 617 525 8582 Jeinarsson@partners.org
Contact: Sarah L Cohen, MD 617 525 8582 scohen20@partners.org
United States
 
NCT01393704
2011-P-000264/1
No
Jon I. Einarsson, Brigham and Women's Hospital
Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • North Shore Medical Center
  • Cedars-Sinai Medical Center
Principal Investigator: Jon I Einarsson, MD,MPH. Brigham and Women's Hospital
Brigham and Women's Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP