The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

Study Overview
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Brief Summary
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Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic 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
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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 injection of Terlipressin in women undergoing laparoscopic myomectomy procedure Arm 2: intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure Arm 3: intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure 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.

Official Title
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The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial

Conditions
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Myoma

Intervention / Treatment
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* Drug: Terlipressin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Women aged 16-45 years Appropriate medical status for laparoscopic surgery (largest myoma ≤15 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: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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 materials that will be used will include blood tests and ultrasound. The study will involve three study arms: Arm 1: intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure Arm 2: intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure Arm 3: intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intracapsular myomectomy Terlipressin injection<br>intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure | Drug: Terlipressin<br>* intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy<br>* Other names: carbitocin;|
| Active Comparator: intracapsular myomectomy Carbetocin injection<br>intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure | Drug: Terlipressin<br>* intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy<br>* Other names: carbitocin;|
| Placebo Comparator: intramyometrial saline<br>intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure | Drug: Terlipressin<br>* intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy<br>* Other names: carbitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy | measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin | compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy | 24 hours | 
| 2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time | 2. To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy | 12 hours |