Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Blood Loss, Surgical	Drug: Vasopressin	Phase 4

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	152 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
Study Start Date :	July 2011
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	June 2015

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.
2. 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.
3. 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].

Secondary Outcome Measures :

1. 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).
2. Total Operation Time [ Time Frame: 5 minutes postoperatively ]
   Time from incision to end of surgery

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes 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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	July 13, 2011
Results First Posted:	April 10, 2017
Last Update Posted:	February 15, 2018
Last Verified:	January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Jon I. Einarsson, 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; Vasoconstrictor Agents; Antidiuretic Agents; Natriuretic Agents; Physiological Effects of Drugs