Myoma
Conditions
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.
Interventions
DRUGTerlipressin
intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy
Sponsors
Wael Elbanna Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 16-45 years 2. Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm) 3. Baseline hemoglobin ≥9 g/dl 4. No contra-indications to the use of glyopressin or carbitocin 5. Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility 6. Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)
Exclusion criteria
1. Previous myomectomy 2. History of bleeding disorders 3. Concurrent anticoagulation therapy 4. History of Uncontrolled ischaemic heart disease 5. Any pelvic abnormalities requiring concomitant surgery 6. Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery 7. Inability to understand and provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactWael El Banna
Backup ContactEsraa mohammad
Outcome results
None listed