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

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

Study Overview

• Status: Unknown
• Conditions: Post Operative Hemorrhage
• Intervention / Treatment: Drug: Tranexamic Acid; Procedure: Pericervical Tourniquet

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohamad A Ismail, MD; Phone Number: 002 01200523523; Email: mohamad.abdelhamid@hotmail.com
• Study Contact Backup: Name: Ahmad M BahaaEldin, MD; Phone Number: 002 01111700556; Email: abahaa0503@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 02002
    • Recruiting
    • Ain shams university maternity hospital
    • Contact: Mohamad A Ismail, MD; Phone Number: 002 01200523523; Email: mohamad.abdelhamid@hotmail.com
    • Contact: Ahmed M Bahaaeldein, MD; Phone Number: 002 01111700556; Email: abahh0503@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tranexamic acid; 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)	Drug: Tranexamic Acid; Other Names: Kapron
Active Comparator: Pericervical Tourniquet; 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	Procedure: Pericervical Tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimated intra-operative blood loss measured in milliliters	first 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for intra-operative blood transfusion	It is indicated when intra-operative blood loss exceeds 15% of the patient's estimated blood volume, which is equal to the patient's weight in kilograms multiplied by 10	1 hour
The need for conversion from myomectomy to hysterectomy	It is indicated when there is uncontrolled intra-operative hemorrhage affecting the patient's vital signs and not responsive to conservative measures or when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids	1 hour
Operative time in minutes		1 hour
Intra-operative or post-operative complications		24 hours
Difference between Pre and post-operative hemoglobin and hematocrit levels	Postoperative hemoglobin and hematocrit levels are to be measured 24 hours after the operation via a venous blood sample).	24 hours
Duration of hospital stay in days		7 days

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Principal Investigator: Ahmad M BahaaEldin, MD, Ain shams university maternity hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: March 27, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 12, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: ASUObGyn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No