RecruitingNot ApplicableNCT05170230

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

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

Sponsor

Wael Elbanna Clinic

Enrollment

99 participants

Start Date

Feb 27, 2022

Study Type

INTERVENTIONAL

Conditions

Myoma

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.

Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 45 Years

Inclusion Criteria6

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 Criteria7

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