INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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THE IMPACT OF TRANEXAMIC ACID USAGE DURING LAPAROSCOPIC MYOMECTOMY

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

Intervention / Treatment
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* Drug: Tranexamic Acid 100 MG/ML
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: myoma uteri appropiate for laparoscopy Exclusion Criteria: malignancy

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: PROSPECTİVELY DOUBLE-BLİND RANDOMİSED CONTROLLED TRİAL
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRANEXAMİC ACİD<br>. 1 gr tranexamic acid in 100 ml salin given in 15 minutes | Drug: Tranexamic Acid 100 MG/ML<br>* 1 GR TRANEXAMİC ACİD İN 100 ML SALİNE SOLUTİON GİVEN İN 15 MİNUTES<br>|
| Placebo Comparator: NO TRANEXAMİC ACİD<br>100 ml salin solution | Drug: Placebos<br>* 100 ML SALİNE SOLUTİON<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of bleeding during operation | total amount of bleeding during surgery | 0 minute - 180 minute | 
| operation duration time | time between initial and end of the surgery | 0 minute - 180 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uterin fibroid, laparoscopic myomectomy