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

Wael Elbanna Clinic

Status: Enrolling

Conditions: Myoma

Treatments: Drug: Terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT05170230

Elbanna_006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 3 patient groups, including a placebo group

intracapsular myomectomy Terlipressin injection

Active Comparator group

Description:

intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure

Treatment:

Drug: Terlipressin

intracapsular myomectomy Carbetocin injection

Active Comparator group

Description:

intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure

Treatment:

Drug: Terlipressin

intramyometrial saline

Placebo Comparator group

Description:

intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure

Treatment:

Drug: Terlipressin