The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets

Myoma Clinical Trial

— myomectomy  

Official title:

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266534
• Other study ID #: Elbanna_008
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: December 2021
• Source: Wael Elbanna Clinic
• Contact: Wael El Banna
• Phone: 01227760402
• Email: waelelbanna[@]drwaelelbanna.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.

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 without using haemostatic tourniquets

• Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets

• Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets 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 computergenerated randomization table with a 1:1:1 group allocation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: December 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

Inclusion Criteri

• Women aged 16-45 yearsAppropriate 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 (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)

Exclusion Criteria

• Open myomectomy using mechanical tourniquet

• 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

Related Conditions & MeSH terms

• Hemorrhage
• Myoma

Intervention

Drug:
• Terlipressin
the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
• Carbetocin
the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
• Saline
the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Locations

Country	Name	City	State
Egypt	Wael El Banna Clinic	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Wael Elbanna Clinic

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 Jan;25(1):187-188. doi: 10.1016/j.jmig.2017.07.027. Epub 2017 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets	the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets	12 hours
Secondary	To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets	To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets	24 hours
Secondary	To measure the operative time in each group without using haemostatic tourniquets	To measure the operative time in each group without using haemostatic tourniquets	24 hours
Secondary	to assess the measure the severity of pain using VAS score	post operative pain VAS score	24 hours

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