Determining the effect of intrauterine instillation of Tranexamic Acid on postoperative hemoglobin level in hysteroscopic myomectomies
Design
A phase 3 randomized controlled double-blinded clinical trial, with parallel groups, of 70 patients. For randomization, the block randomization method and STATA software will be used.
Settings and conduct
1. Study setting: Laparoscopic ward of Arash Women's Hospital in Tehran
2. Blinding: Triple blinded
3. Blinding description: The surgeon is not aware of the presence of tranexamic acid in the media; Therefore, the surgeon, the patient, and the person evaluating the outcome (who is the surgeon herself) do not know the type of media used. The statistician is also unaware of all the processes performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: One submucosal myoma smaller than 4 cm; candidates for hysteroscopic myomectomy.
Non-inclusion criteria: pelvic and uterine disorders; cancer; underlying diseases; using anticoagulant agents
Intervention groups
Intervention group: Tranexamic Acid media.
Control group: Routine Media (Normal Saline).
Main outcome variables
Post-operative hemoglobin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110530006640N8
Registration date:2021-03-07, 1399/12/17
Registration timing:prospective
Last update:2021-03-07, 1399/12/17
Update count:0
Registration date
2021-03-07, 1399/12/17
Registrant information
Name
Zahra Asgari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
asgariza@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intrauterine Instillation of Tranexamic Acid on Postoperative Hemoglobin in Hysteroscopic Myomectomy
Public title
Intrauterine Instillation of Tranexamic Acid in Hysteroscopic Myomectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with one submucosal myoma
Myoma should be completely in the endometrial cavity or extending less than 50% into the myometrium (type 0 and 1, based on FIGO's classification)
Myoma size less than 4 cm in the largest diameter confirmed by accurate transvaginal ultrasound
Candidates for hysteroscopy and myomectomy
Exclusion criteria:
Pelvic infections
History of uterine or cervical cancer; Hematological, cardiovascular, thromboembolic, hepatic, and renal disorders; or Thromboembolic events
Taking anticoagulant agents
Uterine septum, or uterine disorders
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, we will use the block randomization method that will be designed by the epidemiologist using STATA software, version 13. The number of blocks is considered to be 6. The random allocation list will be only available to the operation room nurse. To conceal the random allocation process, 70 treatment cards written in order, will be placed in sealed envelopes. When the surgeon determines the patient's eligibility, the nurse opens the envelope related to the type of intervention and determines the type of media that should be used for the patient according to the contents of the envelope and provides it to the surgeon's assistant, who has no role in conducting the research.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Occasionally, normal saline is used at room temperature as a distending medium in this surgery, which will also be used in the control group. In the intervention group, 0.5 g of tranexamic acid ampoule per 1000 cc of distending medium will be dissolved and used. The surgeon is not aware of the presence of tranexamic acid in the distending medium and immediately after the surgery will record study variables without knowing the type of medium used; Therefore, the surgeon, the patient, and the outcome assessor (the surgeon) are not aware of the type of media and intervention. Also, for data analysis, a statistician who is separate from the study process and is unaware of all the processes will perform analyses. Also, a statistical expert who is not aware of the type of interventions will analyze the data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-12-20, 1399/09/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.937
Health conditions studied
1
Description of health condition studied
Submucous leiomyoma of uterus
ICD-10 code
D25.0
ICD-10 code description
Submucous leiomyoma of uterus
Primary outcomes
1
Description
Hemoglobin Level
Timepoint
Once before surgery and once 24 hours after surgery
Method of measurement
Blood Test
Secondary outcomes
1
Description
Amount of bleeding
Timepoint
Immediately after surgery
Method of measurement
Checklist
2
Description
Surgeon's field of view
Timepoint
Immediately after surgery
Method of measurement
Checklist
3
Description
Duration of surgery
Timepoint
Immediately after surgery
Method of measurement
Checklist
4
Description
The amount of medium used
Timepoint
Immediately after surgery
Method of measurement
Checklist
5
Description
Complications during surgery (Uterine perforation)
Timepoint
Immediately after surgery
Method of measurement
Checklist
6
Description
Completing myomectomy
Timepoint
Immediately after surgery
Method of measurement
Checklist
7
Description
Rare side effects of Tranexamic Acid (Pulmonary embolism)
Timepoint
Immediately after surgery
Method of measurement
Checklist
8
Description
Rare side effects of Tranexamic Acid (Headache)
Timepoint
Immediately after surgery
Method of measurement
Checklist
9
Description
Rare side effects of Tranexamic Acid (abdominal cramps)
Timepoint
Immediately after surgery
Method of measurement
Checklist
10
Description
Rare side effects of Tranexamic Acid (Weakness)
Timepoint
Immediately after surgery
Method of measurement
Checklist
11
Description
Rare side effects of Tranexamic Acid (Back Pain)
Timepoint
Immediately after surgery
Method of measurement
Checklist
12
Description
Rare side effects of Tranexamic Acid (Cramps and Muscle Spasms)
Timepoint
Immediately after surgery
Method of measurement
Checklist
13
Description
Complications during surgery (Thermal injury)
Timepoint
Immediately after surgery
Method of measurement
Checklist
14
Description
Complications during surgery (Overload of distention media)
Timepoint
Immediately after surgery
Method of measurement
Checklist
Intervention groups
1
Description
Intervention group: In the intervention group, tranexamic acid ampoule with a dose of 0.5 g per 1000 cc of normal saline distending medium will be used (considering that the injection dose is 1 gram and can be repeated every 6 to 8 hours and can be used in electrolyte solutions according to the manufacturer's instructions). (Manufactured by Caspian Tamin Pharmaceutical)
Category
Treatment - Drugs
2
Description
Control group: In the control group, according to the routine, only normal saline will be used as distending medium.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr. Zahra Asgari
Street address
َArash Women Hospital, Corner of 162 Alley (Shahid Abdolmajid), Next to Police Station 126, Shahid Baghdarnia Street (North Rashid), After Shahid Bagheri Highway, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
1598116539
Phone
+98 21 7771 9922
Email
asgariza@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Sahraeian
Street address
Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Venus Chegini
Position
Fellowship in Minimally Invasive Gynecologic Surgery
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
venus_chegini@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Asgari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway,
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
00219877719922
Fax
Email
asgariza@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Venus Chegini
Position
Fellowship in Minimally Invasive Gynecologic Surgery
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
Email
venus_chegini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available