Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
Completed · Phase 4
Conditions studied: Blood Loss, Surgical
In brief
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.
Key facts
- Study ID
- NCT01393704
- Run by
- Brigham and Women's Hospital
- People needed
- 152
- Starts
- 2011-07-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2018-02-15
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Brigham&Women's hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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