Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations
Overview
- Phase
- Phase 3
- Intervention
- Misoprostol
- Conditions
- Leiomyoma
- Sponsor
- Ain Shams University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- intraoperative blood loss
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications
Detailed Description
This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital. A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial. The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
Investigators
Dr.Ahmed Elnaggar
DR
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •Premenopausal patients aged between 35 to 50 years old.
- •Five or less symptomatic uterine myomas .
- •Maximum diameter of the largest myoma is 6 cm .
- •All myomas are subserous or intramural.
- •Uterine size less than 24 weeks pregnancy
Exclusion Criteria
- •History of previous surgery.
- •Allergy to Misoprostol.
- •Hypertension.
- •Cardiac and Pulmonary diseases.
- •Patients who have bleeding disorders.
- •Anemia (Hb \< 10g %).
- •Chronic endocrine or metabolic diseases such as Diabetes.
- •Obesity (body mass index \> 30 kg/m2).
- •Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Arms & Interventions
Myomectomy, rectal Misoprostol
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.
Intervention: Misoprostol
Myomectomy, Placebo
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
Intervention: Placebo( for misoprostol)
Outcomes
Primary Outcomes
intraoperative blood loss
Time Frame: time from peritoneum opening till its closure around (1 Hour)