Clinical trial NCT03122782: Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
Official title: Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Surgical Blood Loss
Fibroid
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects must be able to understand, and read and sign the study specific informed consent after fully explanation the nature of the study .
2. Subjects exhibit submucous myoma that are completely within the endometrial cavity or extend less than 50 percent into the myometrium (type 0,i)according to European Society Of Hysteroscopy (ESH).
3. The submucous myoma are less than 4 cm in diameter

Exclusion Criteria:

1. Pregnancy
2. Active Pelvic Infection
3. Present or History of Cervical or Uterine Caner
4. Bleeding Diathesis or patient on anticoagulant
5. Contraindication and /or allergy to medication specified in the treatment protocol
6. History of ischemic heart disease
7. Patient with Cardiopulmonary, Hepatic , and renal diseases
8. Patient with metabolic disorders including diabetes
9. Patients with uterine septum or structural abnormality

Primary outcomes:
measure: Estimated blood loss by comparing changes in hemoglobin level
timeFrame: 24 Hours
measure: Estimated blood loss by comparing changes in hematocrit level
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Ahmed Khairyy Makled, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Amgad Said Abu-Gamra, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Radwa Ali Rasheedy, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Hajer Giuma Soliman, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
References: