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Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tranexamic acid | Active Comparator | bolus intravenous injection of tranexamic acid 10mg/kg (maximum1g) 15 min before incision followed by continuous infusion of 1mg/kg/h dissolved in 1L of saline for 10 h (maximum 1 g/10 h) |
|
| Pericervical Tourniquet | Active Comparator | The tourniquet method will be used where the urinary bladder will be dissected downwards from the lower uterine segment, and then a perforation will be made in the posterior leaflet of the broad ligament bilaterally at the level of uterine isthmus. A tourniquet (using 16- inch Foley catheter) will be passed through the perforation encircling the uterine arteries bilaterally. The Fallopian tubes and the ovaries will be carefully excluded from the line of the tourniquet to avoid direct compression and necrosis. The tourniquet will be released intermittently (at about 30 minutes interval) during the surgery and finally removed after the repair of the uterus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
|
| |
| Pericervical Tourniquet |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated intra-operative blood loss measured in milliliters | first 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The need for intra-operative 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 | 1 hour |
| The need for conversion from myomectomy to hysterectomy |
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Inclusion Criteria:
Clinical symptoms and signs:
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:
Ultrasound criteria of uterine fibroids of included patients:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamad A Ismail, MD | Contact | 01200523523 | 002 | mohamad.abdelhamid@hotmail.com |
| Ahmad M BahaaEldin, MD | Contact | 01111700556 | 002 | abahaa0503@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmad M BahaaEldin, MD | Ain Shams university maternity hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university maternity hospital | Recruiting | Cairo | Cairo Governorate | 02002 | Egypt |
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| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Procedure |
|
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 |
| 1 hour |
| Operative time in minutes | 1 hour |
| Intra-operative or post-operative complications | 24 hours |
| Difference between Pre and post-operative hemoglobin and hematocrit levels | Postoperative hemoglobin and hematocrit levels are to be measured 24 hours after the operation via a venous blood sample). | 24 hours |
| Duration of hospital stay in days | 7 days |