INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY

Uterine Fibroid Clinical Trial

Official title:

THE IMPACT OF TRANEXAMIC ACID USAGE DURING LAPAROSCOPIC MYOMECTOMY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04192643
• Other study ID #: ALKU EDUCATION AND RESEARCH
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2020
• Source: Alkü Alanya Education and Research Hospital
• Contact: MERAL TUGBA ÇIMSIR
• Phone: 05064742272
• Email: dr.tugbaacar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• myoma uteri

• appropiate for laparoscopy

Exclusion Criteria:

• malignancy

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus
• Tranexamic Acid Adverse Reaction
• Uterine Fibroid

Intervention

Drug:
• Tranexamic Acid 100 MG/ML
1 GR TRANEXAMIC ACID IN 100 ML SALINE SOLUTION GIVEN IN 15 MINUTES
• Placebos
100 ML SALINE SOLUTION

Locations

Country	Name	City	State
Turkey	Alku Alanya Education and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Alkü Alanya Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of bleeding during operation	total amount of bleeding during surgery	0 minute - 180 minute
Primary	operation duration time	time between initial and end of the surgery	0 minute - 180 minute