Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy

Summary

Study Design:

Randomized Controlled Clinical Trial.

Study Population:

The study population will be a consecutive series of participants attending the Early Cancer Detection Unit (ECDU) at Ain Shams University Maternity Hospital.

80 women who are scheduled to undergo a hysteroscopic myomectomy will be included and will be randomized into two groups:

Group A: women will undergo a hysteroscopic myomectomy with the use of (TXA) Kapron in the distention medium

Group B: women will undergo hysteroscopic myomectomy with the use of placebo(normal saline in the distention medium).

Randomization will be performed using a Computer-generated randomization system.

The allocated groups will be concealed in serially-numbered sealed opaque envelopes that will only be opened after recruitment.

Patient allocation will be performed prior to the induction of anesthesia by an independent person, who will not otherwise be involved in this study.

The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium.

Therefore, this study will be a randomized double blind prospective clinical

Methodology:

1. Informed written consent obtained from the participant.
2. History

1. Personal history
2. Menstrual history
3. Detailed obstetric history
4. Surgical intervention especially uterine surgeries and any post-operative complication
5. History of drug intake, especially hormonal treatment or anticoagulant therapy.
3. Routine preoperative investigations in addition to a serum pregnancy test if pregnancy is suspected.
4. Physical examination including general, abdominal and pelvic examination.
5. Hysteroscopy will be performed in the early proliferative phase using normal saline as a distention medium.
6. Only in intervention group (TXA group) KAPRON (Tranexamic acid) will be added to the injected media.

* In intervention group 500 mg of Kapron for every 500 ml of distending media will be added.
* In the control group, placebo .i.e. ,normal saline in the same form will be injected inside every 500 ml of the distention medium.
7. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium. Therefore, our study will be a randomized double blind prospective clinical trial.
8. Intraoperative bleeding and quality of view will be observed.
9. A blood sample will be taken from each participant in both groups after 24 hours from the end of the operation for both hemoglobin and hematocrit levels.

Types of outcome measures:

Primary outcome measures:

Estimated Blood loss defined as comparing the hematocrit and hemoglobin at base line (preoperative ) and 24 hours after surgery with the Tranexamic acid compared to the control group.

Secondary outcome measures:

The quality of view, duration of surgery, the volume of injected media, intraoperative complications and the success of the completion of the operation will be secondary outcomes.

Conditions

• Surgical Blood Loss
• Fibroid

Interventions

DRUG

Topical application Tranexamic acid

Tranexamic acid (TXA) will be injected to distinction media during hysteroscopy in myomectomy

DRUG

Placebo (Normal saline)

5ml of normal saline will be added to every 500 ml of distension media

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• Ahmed Khairyy Makled, MD · Ain Shams University

• Amgad Said Abu-Gamra, MD · Ain Shams University

• Radwa Ali Rasheedy, MD · Ain Shams University

• Hajer Giuma Soliman, M.B.B.CH · Ain Shams University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2017-08-31

Completion

2018-01-31