Investigating the effect of intrauterine tranexamic acid on bleeding and the outcome of it in hysteroscopic myomectomy

The effect of intrauterine tranexamic acid in hysteroscopic myomectomy

In this phase3 clinical trial, with case group and control group, 60 patients are randomly divided into two groups of 30 using block randomization. This study is done in a double blind.

Candidates for myomectomy hysteroscopy, who will refer to Afzalipur Hospital in Kerman, will be divided into two placebo or intervention groups, and the intervention group will be given drug (TXA) and the other group will be given placebo (normal saline). The information related to the variables during surgery will be recorded by the operating room nurse and the information related to the variables after surgery by the relevant resident in the data collection form. The data will be recorded by an independent person (statistician) who is not involved in the treatment or data collection. The principal investigator, the patients, and the surgeon performing the surgery will all be blinded to the trial.

Entry: age 18 to 60 years; Solitary myoma; Type 0, 1, and 2 myomas; Myomas smaller than 4 cm non-entry:lack of consent; active pelvic infection; previous history of hysteroscopy; pregnancy; multiple myomas; Uterine abnormalities; myomas larger than 4 cm or grade more than 2; thrombotic diseases; Use of thrombolytic drugs up to 2 weeks after surgery

The intervention group will be injected with a drug (TXA 10 mg/kg from Iran Daru Company) and the other group will be injected with placebo (5cc N.S) before the start of hysteroscopy, and the amount of bleeding, success and complications will be checked.

Age; BMI; type of myomas; the number of myoms; better vision during operation; Bleeding during surgery; operation duration; decrease in hemoglobin; Complications of the operation; The completeness of the operation in one step

In this study, we will use the Restricted randomization method of block block randomization 1:1, and the patients will be divided into two groups: placebo (30 people) or intervention (30 people) and the drug intervention group (tranexamic acid) 10 mg/kg) and placebo (normal saline) will be given to the other group. (Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps researchers to increase the number of samples in cases where intermediate analyzes are needed during the sampling process. allocated to each of the studied groups is the same) the size of all the blocks is equal and in this experiment we will have two groups of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group) had The randomization tool is also used from software allocation random sequence generation software, which in addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method.

An independent person (statistician) who is involved in the treatment or collection of data will be sealed with consecutive numbers. The principal investigator, the patients, and the surgeon performing the surgery will all be blinded to the trial. All participants will undergo a thorough clinical evaluation including: detailed history, general and pelvic examination, transvaginal ultrasound to determine the number, size and location of myomas. After preparing the history and clinical examinations, blood samples of the patients will be prepared and the necessary tests (CBC), PT, PTT and INR will be done for them before the surgery. Also, drug or placebo is prescribed using a specific coding system, and the surgical team and the patient themselves do not know the type of drug used.

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Starting from six months after the publication of the article

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