Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Cedars-Sinai Medical Center; North Shore Medical Center
• Treatments: Arginine Vasopressin; Vasopressins

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.