INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY

Overview

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 Title of Study: “THE IMPACT OF TRANEXAMIC ACID USAGE DURING LAPAROSCOPIC MYOMECTOMY”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Prevention
  • Masking: Single (Investigator)
• Study Primary Completion Date: December 1, 2021

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.

Interventions

• Drug: Tranexamic Acid 100 MG/ML
  • 1 GR TRANEXAMİC ACİD İN 100 ML SALİNE SOLUTİON GİVEN İN 15 MİNUTES
• Drug: Placebos
  • 100 ML SALİNE SOLUTİON

Arms, Groups and Cohorts

• Experimental: TRANEXAMİC ACİD
  • . 1 gr tranexamic acid in 100 ml salin given in 15 minutes
• Placebo Comparator: NO TRANEXAMİC ACİD
  • 100 ml salin solution

Clinical Trial Outcome Measures

Primary Measures

• amount of bleeding during operation
  • Time Frame: 0 minute – 180 minute
  • total amount of bleeding during surgery
• operation duration time
  • Time Frame: 0 minute – 180 minute
  • time between initial and end of the surgery

Participating in This Clinical Trial

Inclusion Criteria

• myoma uteri – appropiate for laparoscopy Exclusion Criteria:

• malignancy

Gender Eligibility: Female

Minimum Age: 16 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Alkü Alanya Education and Research Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: MERAL TUĞBA ÇİMŞİR, ASSOCIATE PROFESSOR – Alkü Alanya Education and Research Hospital
• Overall Contact(s)
  • MERAL TUĞBA ÇİMŞİR, 05064742272, dr.tugbaacar@gmail.com