INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY

June 21, 2020 updated by: MERAL TUĞBA ÇİMŞİR, Alkü Alanya Education and Research Hospital

THE IMPACT OF TRANEXAMIC ACID USAGE DURING LAPAROSCOPIC MYOMECTOMY

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Alku Alanya Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • myoma uteri
  • appropiate for laparoscopy

Exclusion Criteria:

  • malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TRANEXAMİC ACİD
. 1 gr tranexamic acid in 100 ml salin given in 15 minutes
Drug: Tranexamic Acid 100 MG/ML
1 GR TRANEXAMİC ACİD İN 100 ML SALİNE SOLUTİON GİVEN İN 15 MİNUTES
PLACEBO_COMPARATOR: NO TRANEXAMİC ACİD
100 ml salin solution
Drug: Placebos
100 ML SALİNE SOLUTİON

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of bleeding during operation
Time Frame: 0 minute - 180 minute
total amount of bleeding during surgery
0 minute - 180 minute
operation duration time
Time Frame: 0 minute - 180 minute
time between initial and end of the surgery
0 minute - 180 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkü Alanya Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 30, 2020

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 21, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKU EDUCATION AND RESEARCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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