Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2025-12-28 @ 2:29 AM
Study NCT ID:
NCT00799292
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2008-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial
Sponsor:
Ascher-Walsh, Charles, M.D.
Organization:
Study Overview
Official Title:
Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: