Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

Study Overview
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Brief Summary
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The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.

Official Title
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Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail

Conditions
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Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

Intervention / Treatment
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* Drug: preoperative vaginal misoprostol
* Procedure: bilateral uterine artery ligation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs: abnormal uterine bleeding (menorrhagia or/and metrorrhagia) pain (dull aching lower abdominal pain or dysmenorrhea) pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache) progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis: maximum diameter of the largest fibroid is greater than 4 cm maximum number of uterine myomas is not to be more than 5 myomas uterine fibroid may be subserous or intramural Exclusion Criteria: obesity (BMI >30 kg/m2) cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl) patients known to be allergic to prostaglandin preparations patients who received preoperative hormonal therapy (GnRH analogue) patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia patients with positive pregnancy test virgin patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: misoprostol group<br>preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy | Drug: preoperative vaginal misoprostol<br>* preoperative vaginal misoprostol 400 micrograms 1 hour before surgery<br>* Other names: cytotec;|
| Active Comparator: uterine artery ligation group<br>bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy | Procedure: bilateral uterine artery ligation<br>* bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures<br>* Other names: devascularization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated intraoperative blood loss measured in milliliters |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the need of intra-operative blood transfusion | Below a hemoglobin concentration of 7 g/dL requiring blood transfusion. It is indicated when intra-operative blood loss exceeds 15% of the patient's estimated blood volume, which is equal to the patient's weight in kilograms multiplied by 10). | 60 min | 
| the need for conversion from myomectomy to hysterectomy | It is indicated when there is uncontrolled intra-operative hemorrhage affecting the patient's vital signs and not responsive to conservative measures when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids | 60 min | 
| operative time in minutes |  | 60 min | 
| intraoperative or postoperative complications |  | 24 hours | 
| differance between pre and post operative hemoglobin and hematocrit levels |  | 24 hours | 
| duration of hospital stay in days |  | 7 days |