NCT04192643

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

December 4, 2019

Last Update Submit

June 21, 2020

Conditions

Uterine FibroidMyoma;UterusTranexamic Acid Adverse Reaction

Keywords

uterin fibroid, laparoscopic myomectomy

Outcome Measures

Primary Outcomes (2)

  • amount of bleeding during operation

    total amount of bleeding during surgery

    0 minute - 180 minute

  • operation duration time

    time between initial and end of the surgery

    0 minute - 180 minute

Study Arms (2)

TRANEXAMİC ACİD

EXPERIMENTAL

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

Drug: Tranexamic Acid 100 MG/ML

NO TRANEXAMİC ACİD

PLACEBO COMPARATOR

100 ml salin solution

Drug: Placebos

Interventions

Tranexamic Acid 100 MG/MLDRUG

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

TRANEXAMİC ACİD
PlacebosDRUG

100 ML SALİNE SOLUTİON

NO TRANEXAMİC ACİD

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • myoma uteri
  • appropiate for laparoscopy

You may not qualify if:

  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alku Alanya Education and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

LeiomyomaMyofibroma

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

MERAL TUĞBA ÇİMŞİR

CONTACT

05064742272dr.tugbaacar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: PROSPECTİVELY DOUBLE-BLİND RANDOMİSED CONTROLLED TRİAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 10, 2019

Study Start

December 30, 2020

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

TU(1)