Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy

Ain Shams Maternity Hospital

Status and phase: Unknown; Phase 3

Conditions: Post Operative Hemorrhage

Treatments: Procedure: Pericervical Tourniquet; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02733952

ASUObGyn

Details and patient eligibility

About

Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy

Full 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

Enrollment: 70 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

tranexamic acid

Active Comparator group

Description:

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)

Treatment:

Drug: Tranexamic Acid

Pericervical Tourniquet

Active Comparator group

Description:

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

Treatment:

Procedure: Pericervical Tourniquet