Back to resultsThe Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:
Primary Purpose
Myoma
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Terlipressin
Sponsored by
About this trial
This is an interventional treatment trial for Myoma
Eligibility Criteria
Inclusion Criteria:
- Women aged 16-45 years
- Appropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
- Baseline hemoglobin ≥9 g/dl
- No contra-indications to the use of glyopressin or carbitocin
- Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
- Not pregnant at the time of presentation
Exclusion Criteria:
- Previous myomectomy
- History of bleeding disorders
- Concurrent anticoagulation therapy
- History of Uncontrolled ischaemic heart disease
- Any pelvic abnormalities requiring concomitant surgery
- Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
- Inability to understand and provide written informed consent.
Sites / Locations
- Wael El-Banna ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
intramyometrial Terlipressin injection
intramyometrial Carbetocin injection
intramyometrial saline injection
Arm Description
intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural Terlipressin will be injected, and then the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)
intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets. (After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural carbitocin will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)
intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets. After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural saline as a aplacebo will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated) and amount of blood loss and operative time is compared between all arms
Outcomes
Primary Outcome Measures
To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets.
To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets( measuring the amount of blood loss in mm )
Secondary Outcome Measures
1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets.
1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets. ( to evaluate the change in hemoglobin level between before and after the operation )
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05242783
Brief Title
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:
Official Title
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets: Double Blinded Randomized Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wael Elbanna Clinic
4. Oversight
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
the study aims to evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing abdominal myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
Detailed Description
This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects.
The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:
Arm 1: intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets(placebo).
Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double blinded randomized
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intramyometrial Terlipressin injection
Arm Type
Active Comparator
Arm Description
intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
(After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural Terlipressin will be injected, and then the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)
Arm Title
intramyometrial Carbetocin injection
Arm Type
Active Comparator
Arm Description
intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
(After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural carbitocin will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)
Arm Title
intramyometrial saline injection
Arm Type
Placebo Comparator
Arm Description
intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural saline as a aplacebo will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated) and amount of blood loss and operative time is compared between all arms
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Other Intervention Name(s)
carbitocin, saline (placebo)
Intervention Description
intramyometrial Terlipressin versus carbitocin versus saline(placebo) injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
Primary Outcome Measure Information:
Title
To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets.
Description
To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets( measuring the amount of blood loss in mm )
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets.
Description
1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets. ( to evaluate the change in hemoglobin level between before and after the operation )
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with fibroids undergo open myomectomy using hemostatic tournique
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 16-45 years
Appropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
Baseline hemoglobin ≥9 g/dl
No contra-indications to the use of glyopressin or carbitocin
Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
Not pregnant at the time of presentation
Exclusion Criteria:
Previous myomectomy
History of bleeding disorders
Concurrent anticoagulation therapy
History of Uncontrolled ischaemic heart disease
Any pelvic abnormalities requiring concomitant surgery
Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
Inability to understand and provide written informed consent.
Facility Information:
Facility Name
Wael El-Banna Clinic
City
Maadi
State/Province
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wael SS El-Banna, consultant
Phone
01227760402
Email
dr.wael.ss.elbanna@gmail.com,
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26550945
Citation
Song T, Kim MK, Kim ML, Jung YW, Yun BS, Seong SJ. Use of vasopressin vs epinephrine to reduce haemorrhage during myomectomy: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:177-181. doi: 10.1016/j.ejogrb.2015.10.003. Epub 2015 Oct 24.
Results Reference
background
PubMed Identifier
29679676
Citation
Parker WH, Berek JS, Pritts EA, Olive D, Chalas E, Clarke-Pearson D. Regarding "Incidence of Occult Uterine Malignancy Following Vaginal Hysterectomy with Morcellation". J Minim Invasive Gynecol. 2018 Sep-Oct;25(6):1113. doi: 10.1016/j.jmig.2018.04.008. Epub 2018 Apr 18. No abstract available.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/21666469/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/25767949/
Description
Related Info
Learn more about this trial
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:
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