Post Operative Hemorrhage
Conditions
Brief summary
Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
Detailed description
this study aims at comparing between different methods to decrease blood loss in trans-abdominal myomectomy. this study compares between medical (intravenous tranexamic acid administration) and non medical (pericervical tourniquet) methods in decreasing blood loss intra operative
Interventions
DRUGTranexamic Acid
PROCEDUREPericervical Tourniquet
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). All women with clinical presentation suggestive of uterine fibroid will undergo abdominal and trans-vaginal ultrasound to confirm the clinical diagnosis and to exclude patients with: * Submucous uterine myomas. * Cervical or supracervical myomas. * Broad ligamentary and pedunculated myomas. * Associated pelvic pathology. Ultrasound criteria of uterine fibroids of included patients: * Maximum diameter of the largest fibroid is greater than 4cm. * Maximum number of uterine myomas is not to be more than 5 myomas. * Uterine fibroid may be subserous or intramural.
Exclusion criteria
* Obesity (body mass index \>30 kg/m2). * Cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10gm/dl). * Patients known to be allergic to tranexamic acid. * Patients who received pre-operative hormonal therapy (such as a 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 intra-operative blood loss measured in milliliters | first 24 hours postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The need for conversion from myomectomy to hysterectomy | 1 hour | It is indicated when there is uncontrolled intra-operative hemorrhage affecting the patient's vital signs and not responsive to conservative measures or when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids |
| Operative time in minutes | 1 hour | — |
| The need for intra-operative blood transfusion | 1 hour | 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 |
| Difference between Pre and post-operative hemoglobin and hematocrit levels | 24 hours | Postoperative hemoglobin and hematocrit levels are to be measured 24 hours after the operation via a venous blood sample). |
| Duration of hospital stay in days | 7 days | — |
| Intra-operative or post-operative complications | 24 hours | — |
Countries
Egypt
Contacts
Primary ContactMohamad A Ismail, MD
Backup ContactAhmad M BahaaEldin, MD
Outcome results
None listed