Myoma
Conditions
Brief 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.
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 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
Interventions
DRUGTerlipressin
the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
DRUGCarbetocin
the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
DRUGSaline
the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
Sponsors
Wael Elbanna Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double Blinded Randomized Placebo-Controlled Trial
Intervention model description
Double Blinded Randomized Placebo-Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets | 12 hours | the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets | 24 hours | To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets |
| To measure the operative time in each group without using haemostatic tourniquets | 24 hours | To measure the operative time in each group without using haemostatic tourniquets |
| to assess the measure the severity of pain using VAS score | 24 hours | post operative pain VAS score |
Countries
Egypt
Contacts
Primary ContactWael El Banna
Backup ContactEsraa mohammad
Outcome results
None listed