INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY

Alkü Alanya Education and Research Hospital

Status: Unknown

Conditions: Uterine Fibroid; Tranexamic Acid Adverse Reaction; Myoma;Uterus

Treatments: Drug: Tranexamic Acid 100 MG/ML; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04192643

ALKU EDUCATION AND RESEARCH

Details and patient eligibility

About

This research is planned as a randomised double-blind controlled trial. interventions to reduce haemorrhage during laparoscopic myomectomy for fiboids is important. İntraoperative Tranexamic acid usage can reduce haemorrhage and related symptoms when given during laparoscopic myomectomy. There is no randomised controlled trials in literature about tranexamic acid usage in laparoscopic gynecological operations.

Full description

researchers planned this trial by firstly randomising the patients. 1 gr tranexamic acid in 100 ml salin will bi given by initial of the anesthesia of the patient, the other group will be taken only 100ml saline solution. Randomising will be double blind and only anesthesiologist will see if the paient is in working group or control group. Than researchers provide laparoscopic myomectomy with same prothocol to each patient. At the end of the operation, researchers will record all the parameters during operation like; operation starting and ending time, the amount of bleeding, time of suturing, the size, location and count of myoma uteri, complications, weight of myoma uteri and the change of haemoglobine levels before and after operation.

Enrollment: 60 estimated patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• myoma uteri
• appropiate for laparoscopy

Exclusion criteria

• malignancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

TRANEXAMİC ACİD

Experimental group

Description:

. 1 gr tranexamic acid in 100 ml salin given in 15 minutes

Treatment:

Drug: Tranexamic Acid 100 MG/ML

NO TRANEXAMİC ACİD

Placebo Comparator group

Description:

100 ml salin solution

Treatment:

Drug: Placebos