Triple Tourniquets With or Without Tranexamic Acid for Reducing Blood Loss at Open Myomectomy (TTT)

Aswan University Hospital

Status: Unknown

Conditions: Myoma

Treatments: Procedure: Triple tourniquets; Drug: TA; Other: placebo to TA

Study type: Interventional

Funder types: Other

Identifiers

NCT03880604

aswu/207/19

Details and patient eligibility

About

In this study, the investigators will investigate the effectiveness of an intravenous tranexamic acid plus triple tourniquets compared with triple tourniquets alone for the reduction of blood loss at the time of myomectomy

Full description

An RCT investigated the efficacy of intravenous tranexamic acid (TA) during abdominal myomectomy. The study was unable to demonstrate any significant impact on blood loss, duration of surgery or need for blood transfusionHemostatic tourniquets to reduce intra-operative bleeding have long been available, but data on their efficacy from controlled trials are lacking. The investigators set out to evaluate the use of triple tourniquets plus tranexamic acid in controlled conditions and for the first time to investigate the hypothesis that adding tranexamic acid to tourniquet around the uterine artery reduces postoperative bleeding from the uterine incisions, a well-recognized sequel to surgery

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

Triple tourniquets plus TA

Active Comparator group

Description:

A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus1-gram tranexamic acid (10 ml) in 100 ml saline infusion

Treatment:

Drug: TA

Procedure: Triple tourniquets

Triple tourniquets plus placebo to TA

Active Comparator group

Description:

A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion

Treatment:

Other: placebo to TA

Procedure: Triple tourniquets