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NCT00799292 · ClinicalTrials.gov registry record · Phase 4
Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial
A Phase 4 study of Blood Loss During Vaginal Hysterectomy, sponsored by Ascher-Walsh, Charles, M.D..
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT00799292 is a Phase 4 study of Blood Loss During Vaginal Hysterectomy that has completed, run by Ascher-Walsh, Charles, M.D.. The registered enrollment target is 58 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00799292, a Phase 4 study of Blood Loss During Vaginal Hysterectomy, has completed, sponsored by Ascher-Walsh, Charles, M.D..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Vasopressin
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2004-01 |
| Est. Completion | 2005-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00799292
The ClinicalTrials.gov registry entry for NCT00799292 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascher-Walsh, Charles, M.D., which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Blood Loss During Vaginal Hysterectomy appearing as the primary indexed condition, and to 1 intervention - of which Vasopressin is the first listed.
NCT00799292 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00799292 about?
NCT00799292 is a clinical study titled "Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial". 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 demonstrate...
What is the current status of trial NCT00799292?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2004-01. Estimated completion is 2005-01.
What conditions does trial NCT00799292 study?
This clinical trial studies the following conditions: Blood Loss During Vaginal Hysterectomy.
What interventions are being tested in trial NCT00799292?
The interventions under investigation include: Vasopressin (DRUG).
Who is sponsoring clinical trial NCT00799292?
This trial is sponsored by Ascher-Walsh, Charles, M.D., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00799292 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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