Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
Conditions
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.
Interventions
DRUGpreoperative vaginal misoprostol
preoperative vaginal misoprostol 400 micrograms 1 hour before surgery
PROCEDUREbilateral uterine artery ligation
bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| estimated intraoperative blood loss measured in milliliters | 60 min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| operative time in minutes | 60 min | — |
| 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). |
| differance between pre and post operative hemoglobin and hematocrit levels | 24 hours | — |
| duration of hospital stay in days | 7 days | — |
| intraoperative or postoperative complications | 24 hours | — |
Countries
Egypt
Contacts
Primary Contactwalid basuony basuony, lecturer
Outcome results
None listed