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

Aswan University Hospital100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Myoma

Interventions

Triple tourniquetsPROCEDURE

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

TADRUG

1-gram tranexamic acid (10 ml) in 100 ml saline infusion

placebo to TAOTHER

placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Aswan University Hospital

Aswān, Egypt

RECRUITING

Outcomes

Primary Outcomes

Mean amount of intraoperative blood loss

measure the mean amount of intraoperative blood loss by gravimetric methods

Time frame: intraoperative

Secondary Outcomes

The number of patients needs for blood transfusion

Calculation the number of patients needs for blood transfusion

Time frame: 24 hours post delivery

Central Contacts

hany f sallam, md

CONTACT

0102236052 hany.farouk@aswu.edu.eg

nahla w shady, md

CONTACT

01092440504 nahla.elsayed@aswu.edu.eg

Data from ClinicalTrials.gov

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