Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/17/2018 |
| Start Date: | July 2011 |
| End Date: | June 2015 |
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.
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.
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.
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.
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