Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy

Aswan University Hospital

Status: Unknown

Conditions: Myoma

Treatments: Drug: vasopressin; Other: placebo to TA; Drug: Topical TA

Study type: Interventional

Funder types: Other

Identifiers

NCT03880045

aswu/206/19

Details and patient eligibility

About

In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy

Full description

Uterine fibroids are the most common female pelvic tumors occurring in about 15% to 30% of women in the reproductive age group. The major problem with myomectomy is excessive bleeding from the increased uterine blood supply. This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy. Knowledge of the effectiveness of the interventions used to reduce blood loss during myomectomy is essential to enable evidence-based clinical decisions. Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration. Studies from cardiac and orthopedic surgery have shown an equal or superior effect of topical compared with intravenous TA on both bleeding and transfusion requirement. Topical treatment is cost-effective, and adverse effects or drug interactions have not been reported

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
• Age ≥ 18 years and ≤ 50 years
• Pre-operative hemoglobin >8 g/dl
• Ability to understand and the willingness to sign a written informed consent.
• Admissible medical/surgical history
• Five or less symptomatic uterine myomas
• All myomas are subserous or intramural.
• Uterine size less than 24 weeks of pregnancy

Exclusion criteria

• Patients who have had a prior abdominal myomectomy
• Post-menopausal women
• Patients with known bleeding/clotting disorders
• Patients with a history of gynecologic malignancy
• Hypertension.
• Cardiac and Pulmonary Diseases.
• Obesity (body mass index > 30 kg/m2).
• History of allergic reactions attributed to misoprostol
• Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Topical TA plus vasopressin

Active Comparator group

Description:

Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%

Treatment:

Drug: Topical TA

Drug: vasopressin

placebo to TA plus vasopressin

Active Comparator group

Description:

Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus placebo to tranexamic acid

Treatment:

Other: placebo to TA

Drug: vasopressin