The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations
- Registration Number
- NCT05170230
- Lead Sponsor
- Wael Elbanna Clinic
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 99
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intracapsular myomectomy Carbetocin injection Terlipressin intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure intramyometrial saline Terlipressin intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure intracapsular myomectomy Terlipressin injection Terlipressin intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure
- Primary Outcome Measures
Name Time Method intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy 12 hours measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy
- Secondary Outcome Measures
Name Time Method 1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin 24 hours compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy
2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time 12 hours 2. To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy
Trial Locations
- Locations (1)
Wael El Banna Clinic
🇪🇬Maadi, Egypt