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INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY

THE IMPACT OF TRANEXAMIC ACID USAGE DURING LAPAROSCOPIC MYOMECTOMY

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04192643
Enrollment
60
Registered
2019-12-10
Start date
2020-12-30
Completion date
2021-12-30
Last updated
2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroid, Myoma;Uterus, Tranexamic Acid Adverse Reaction

Keywords

uterin fibroid, laparoscopic myomectomy

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.

Interventions

1 GR TRANEXAMİC ACİD İN 100 ML SALİNE SOLUTİON GİVEN İN 15 MİNUTES

DRUGPlacebos

100 ML SALİNE SOLUTİON

Sponsors

Alkü Alanya Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention model description

PROSPECTİVELY DOUBLE-BLİND RANDOMİSED CONTROLLED TRİAL

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* myoma uteri * appropiate for laparoscopy

Exclusion criteria

* malignancy

Design outcomes

Primary

MeasureTime frameDescription
amount of bleeding during operation0 minute - 180 minutetotal amount of bleeding during surgery
operation duration time0 minute - 180 minutetime between initial and end of the surgery

Countries

Turkey (Türkiye)

Contacts

Primary ContactMERAL TUĞBA ÇİMŞİR
dr.tugbaacar@gmail.com05064742272

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026