Blood Loss During Vaginal Hysterectomy Clinical Trial
Official title:
Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy
| NCT number | NCT00799292 |
| Other study ID # | ASW 123 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | January 2004 |
| Est. completion date | January 2005 |
| Verified date | November 2008 |
| Source | Ascher-Walsh, Charles, M.D. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | January 2005 |
| Est. primary completion date | January 2005 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - women greater that 18 undergoing vaginal hysterectomy for any indication, with or without concomitant procedures Exclusion Criteria: - women with a significant medical condition, including severe liver disease, congestive heart failure, documented coronary artery disease, impaired renal function determined by an elevated serum creatinine, asthma with steroid use in the past year, and migraines |
| Country | Name | City | State |
|---|---|---|---|
| United States | Columbia University Medical Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Ascher-Walsh, Charles, M.D. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intra-operative Blood Loss During Vaginal Hysterectomy | Blood loss will be assessed at the end of the operative procedure | ||
| Primary | Estimated Blood Loss | Estimated blood loss as mL | Duration of vaginal hysterectomy | |
| Secondary | Operative Time and Complication Rates | Duration of procedures and immediate post-operative stay in hospital |