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Sponsored by: |
Ascher-Walsh, Charles, M.D. |
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Information provided by: | Ascher-Walsh, Charles, M.D. |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Blood Loss During Vaginal Hysterectomy |
Drug: Vasopressin Other: No injection |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy |
Enrollment: | 58 |
Study Start Date: | January 2004 |
Study Completion Date: | January 2005 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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No injection: No Intervention
Patients did not receive an injection at cervix prior to beginning the procedure
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Other: No injection
Patients did not receive an injection of medication at cervix prior to beginning of procedure
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Injection of vasopressin: Experimental
Patients will be randomized to receive 20cc of dilute vasopressin (20units in 50cc normal saline)injected at cervix at beginning of the hysterectomy
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Drug: Vasopressin
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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Charles Ascher-Walsh, MD, MPH | Mt Sinai School of Medicine, Dept Obstetrics and Gynecology |
Responsible Party: | Mt Sinai School of Medicine, Department of Obstetrics and Gynecology ( Charles Ascher-Walsh MD, MPH ) |
Study ID Numbers: | ASW 123 |
Study First Received: | October 21, 2008 |
Results First Received: | October 21, 2008 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00799292 History of Changes |
Health Authority: | United States: Institutional Review Board |
Arginine Vasopressin Arginine Vasoconstrictor Agents Vasopressins |
Cardiovascular Agents Hemorrhage Hemostatics |
Coagulants Physiological Effects of Drugs Hematologic Agents Cardiovascular Agents Hemorrhage Hemostatics Pharmacologic Actions |
Arginine Vasopressin Pathologic Processes Natriuretic Agents Therapeutic Uses Vasopressins Vasoconstrictor Agents Antidiuretic Agents |