INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY
Primary Purpose
Uterine Fibroid, Myoma;Uterus, Tranexamic Acid Adverse Reaction
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tranexamic Acid 100 MG/ML
Placebos
Sponsored by
About this trial
This is an interventional prevention trial for Uterine Fibroid focused on measuring uterin fibroid, laparoscopic myomectomy
Eligibility Criteria
Inclusion Criteria:
- myoma uteri
- appropiate for laparoscopy
Exclusion Criteria:
- malignancy
Sites / Locations
- Alku Alanya Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TRANEXAMİC ACİD
NO TRANEXAMİC ACİD
Arm Description
. 1 gr tranexamic acid in 100 ml salin given in 15 minutes
100 ml salin solution
Outcomes
Primary Outcome Measures
amount of bleeding during operation
total amount of bleeding during surgery
operation duration time
time between initial and end of the surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04192643
First Posted
December 4, 2019
Last Updated
June 21, 2020
Sponsor
Alkü Alanya Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04192643
Brief Title
INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY
Official Title
THE IMPACT OF TRANEXAMIC ACID USAGE DURING LAPAROSCOPIC MYOMECTOMY
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alkü Alanya Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid, Myoma;Uterus, Tranexamic Acid Adverse Reaction
Keywords
uterin fibroid, laparoscopic myomectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
PROSPECTİVELY DOUBLE-BLİND RANDOMİSED CONTROLLED TRİAL
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TRANEXAMİC ACİD
Arm Type
Experimental
Arm Description
. 1 gr tranexamic acid in 100 ml salin given in 15 minutes
Arm Title
NO TRANEXAMİC ACİD
Arm Type
Placebo Comparator
Arm Description
100 ml salin solution
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 100 MG/ML
Intervention Description
1 GR TRANEXAMİC ACİD İN 100 ML SALİNE SOLUTİON GİVEN İN 15 MİNUTES
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
100 ML SALİNE SOLUTİON
Primary Outcome Measure Information:
Title
amount of bleeding during operation
Description
total amount of bleeding during surgery
Time Frame
0 minute - 180 minute
Title
operation duration time
Description
time between initial and end of the surgery
Time Frame
0 minute - 180 minute
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
myoma uteri
appropiate for laparoscopy
Exclusion Criteria:
malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MERAL TUĞBA ÇİMŞİR
Phone
05064742272
Email
dr.tugbaacar@gmail.com
Facility Information:
Facility Name
Alku Alanya Education and Research Hospital
City
Antalya
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MERAL TUĞBA ÇİMŞİR
Phone
05064742272
Email
DR.TUGBAACAR@GMAİL.COM
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY
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