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

Primary Purpose

Post Operative Hemorrhage

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Tranexamic Acid

Pericervical Tourniquet

About this trial

This is an interventional prevention trial for Post Operative Hemorrhage

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Ain shams university maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

tranexamic acid

Pericervical Tourniquet

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Estimated intra-operative blood loss measured in milliliters

Secondary Outcome Measures

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

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

Operative time in minutes

Intra-operative or post-operative complications

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).

Duration of hospital stay in days

Full Information

NCT ID

NCT02733952

First Posted

March 27, 2016

Last Updated

April 6, 2016

Sponsor

Ain Shams Maternity Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02733952

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tranexamic acid

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Pericervical Tourniquet

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Other Intervention Name(s)

Kapron

Intervention Type

Procedure

Intervention Name(s)

Pericervical Tourniquet

Primary Outcome Measure Information:

Title

Estimated intra-operative blood loss measured in milliliters

Time Frame

first 24 hours postoperative

Secondary Outcome Measure Information:

Title

The need for intra-operative blood transfusion

Description

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

Time Frame

1 hour

Title

The need for conversion from myomectomy to hysterectomy

Description

Time Frame

1 hour

Title

Operative time in minutes

Time Frame

1 hour

Title

Intra-operative or post-operative complications

Time Frame

24 hours

Title

Difference between Pre and post-operative hemoglobin and hematocrit levels

Description

Postoperative hemoglobin and hematocrit levels are to be measured 24 hours after the operation via a venous blood sample).

Time Frame

24 hours

Title

Duration of hospital stay in days

Time Frame

7 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamad A Ismail, MD

Phone

01200523523

Ext

002

mohamad.abdelhamid@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmad M BahaaEldin, MD

Phone

01111700556

Ext

002

abahaa0503@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmad M BahaaEldin, MD

Organizational Affiliation

Ain Shams university maternity hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ain shams university maternity hospital

City

Cairo

ZIP/Postal Code

02002

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamad A Ismail, MD

Phone

01200523523

Ext

002

mohamad.abdelhamid@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ahmed M Bahaaeldein, MD

Phone

01111700556

Ext

002

abahh0503@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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