Clinical trial NCT05266534: The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets
Official title: The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myoma
Lead sponsor: Wael Elbanna Clinic
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 162
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blinded Randomized Placebo-Controlled Trial
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets
timeFrame: 12 hours
Secondary outcomes:
measure: To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets
timeFrame: 24 hours
measure: To measure the operative time in each group without using haemostatic tourniquets
timeFrame: 24 hours
measure: to assess the measure the severity of pain using VAS score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Wael El Banna Clinic
Study officials:
References:
citation: 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. No abstract available.