Topical Tranexamic Acid Plus Perivascular Vasopressin to Decrease Bleeding at the Time of Abdominal Myomectomy: A Double-blinded Randomized Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- measure will be Mean amount of blood loss
Study Overview
Brief Summary
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
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
A double-blinded randomized controlled stud
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Topical TA plus vasopressin
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%
Intervention: Topical TA (Drug)
Topical TA plus vasopressin
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%
Intervention: vasopressin (Drug)
placebo to TA plus vasopressin
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
Intervention: vasopressin (Drug)
placebo to TA plus vasopressin
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
Intervention: placebo to TA (Other)
Outcomes
Primary Outcomes
measure will be Mean amount of blood loss
Time Frame: intraoperative
measure will be Mean amount of blood loss by gravimetric methods
Secondary Outcomes
- the number of the patients need of blood transfusion(24 hours post delivery)
Investigators
hany farouk
Principal Investigator
Aswan University Hospital