Columbia University Medical Center
New York, 10032, United States
NCT Number: NCT00799292
Vasoconstrictive agents are increasingly being used in order to decrease blood loss during vaginal hysterectomy. The first reported study of the use of a vasoconstrictive agent for this purpose was on the use of epinephrine injected intracervically preoperatively by England, et. al. They demonstrated a significant decrease in the amount of blood lost during the surgery but also demonstrated a significant increase in the risk of post-operative infections, most frequently a vaginal cuff cellulitis requiring antibiotic treatment. Recent studies using vasopressin as the vasoconstrictive agent have also found the same significant decrease in blood loss while not demonstrating a difference in the rate of post-operative infections. The more recent studies by Speer and Unger , and Kammerer-Doak, et.al. were larger, better designed studies and are considered more credible. More surgeons are therefore injecting vasopressin intracervically preoperatively.
Some surgeons believe that the injection of vasopressin intracervically prior to the initial incision of a vaginal hysterectomy effects surgical plains and therefore makes the surgical dissection more difficult. This is thought to possibly both add to operative time and increase the rate of complications. The aforementioned studies used the injection of saline as a control for the injection of vasopressin or epinephrine. To date, no study has compared the use of vasopressin versus no injection in a controlled, randomized manner. We do not know if the injection of saline intracervically may actually increase the amount of bleeding over the baseline and therefore the decreased blood loss caused by the injection of vasopressin my actually be overestimated.
We propose to compare the effects of injecting vasopressin intracervically preoperatively versus no preoperative medication. We will not only evaluate the amount of operative blood loss, but also compare operative time and complication rates.
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Notify Me18 year and older
Female
Interventional
Phase 4
New York, 10032, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20cc of dilute vasopressin (20units in 50cc normal saline). At beginning of the procedure 5cc injected were injected at 2,4,8 and 10 o'clock on the cervix
Time frame: Blood loss will be assessed at the end of the operative procedure
Time frame: Duration of vaginal hysterectomy
Estimated blood loss as mL
Time frame: Duration of procedures and immediate post-operative stay in hospital
Ascher-Walsh, Charles, M.D.
Indiv
Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy
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