Hysterectomy
Conditions
Brief summary
In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect
Interventions
1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
DRUGplacebo
1 vaginal tablet of placebo 60 minutes before surgery
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Patients presenting for hysterectomy for any benign indication including uterine fibroids. * Age ≥ 18 years * Pre-operative hemoglobin \>8 g/dl * Willing to have dinoprostone or a placebo prior to hysterectomy * Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
* • Patients with known or suspected endometrial/ovarian/cervical cancer. * Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia. * Patients currently undergoing treatment for any type of cancer. * Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism) * History of allergic reactions to dinoprostone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| decrease blood loss during hysterectomy | intraoperative | decrease blood loss during hysterectomy in ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative hemoglobin level | 24 hours | postoperative hemoglobin level in gm/dl |
Countries
Egypt
Outcome results
None listed