Phase 4
N=152
Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial
Blood Loss, Surgical
Bottom Line
View on ClinicalTrials.gov: NCT01393704 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage — -4.4; -4.0 hematocrit percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vasopressin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage |
-4.4; -4.0 | — |
| PRIMARY Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss |
106.2; 119 | — |
| PRIMARY Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation |
178; 198 | — |
| SECONDARY Number of Participants With Peri-operative Complications |
9; 10 | — |
| SECONDARY Total Operation Time |
176.8; 165.5 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01393704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.