INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY

NCT ID: NCT04192643

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-30

Study Completion Date

2021-12-30

Brief Summary

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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

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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.

Conditions

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Uterine Fibroid Myoma;Uterus Tranexamic Acid Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

PROSPECTİVELY DOUBLE-BLİND RANDOMİSED CONTROLLED TRİAL
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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TRANEXAMİC ACİD

. 1 gr tranexamic acid in 100 ml salin given in 15 minutes

Group Type EXPERIMENTAL

Tranexamic Acid 100 MG/ML

Intervention Type DRUG

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

NO TRANEXAMİC ACİD

100 ml salin solution

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

100 ML SALİNE SOLUTİON

Interventions

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Tranexamic Acid 100 MG/ML

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

Intervention Type DRUG

Placebos

100 ML SALİNE SOLUTİON

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* myoma uteri
* appropiate for laparoscopy

Exclusion Criteria

* malignancy
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alkü Alanya Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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MERAL TUĞBA ÇİMŞİR

ASSOCIATE PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alku Alanya Education and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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MERAL TUĞBA ÇİMŞİR

Role: CONTACT

05064742272

Facility Contacts

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MERAL TUĞBA ÇİMŞİR

Role: primary

Other Identifiers

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ALKU EDUCATION AND RESEARCH

Identifier Type: -

Identifier Source: org_study_id

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