INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY

Not Applicable

• Conditions: Uterine Fibroid; Myoma;Uterus; Tranexamic Acid Adverse Reaction
• Interventions: Drug: Placebos; Drug: Tranexamic Acid 100 MG/ML

• Registration Number: NCT04192643
• Lead Sponsor: Alkü Alanya Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-21
• Last Update Posted: 2020-06-23
• Study Start: 2020-12-30
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• myoma uteri
• appropiate for laparoscopy

Exclusion Criteria

• malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NO TRANEXAMİC ACİD	Placebos	100 ml salin solution
TRANEXAMİC ACİD	Tranexamic Acid 100 MG/ML	. 1 gr tranexamic acid in 100 ml salin given in 15 minutes

Primary Outcome Measures

Name	Time	Method
operation duration time	0 minute - 180 minute	time between initial and end of the surgery
amount of bleeding during operation	0 minute - 180 minute	total amount of bleeding during surgery

Trial Locations

Locations (1)

Alku Alanya Education and Research Hospital; 🇹🇷 Antalya, Turkey