Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
Phase 4
- Conditions
- Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
- Interventions
- Procedure: bilateral uterine artery ligation
- Registration Number
- NCT02643186
- Lead Sponsor
- Ain Shams Maternity Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 62
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description uterine artery ligation group bilateral uterine artery ligation bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy misoprostol group preoperative vaginal misoprostol preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy
- Primary Outcome Measures
Name Time Method estimated intraoperative blood loss measured in milliliters 60 min
- Secondary Outcome Measures
Name Time Method duration of hospital stay in days 7 days operative time in minutes 60 min the need for conversion from myomectomy to hysterectomy 60 min 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
differance between pre and post operative hemoglobin and hematocrit levels 24 hours the need of intra-operative blood transfusion 60 min 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).
intraoperative or postoperative complications 24 hours
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Egypt