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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-27

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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intracapsular myomectomy Terlipressin injection

intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy

intracapsular myomectomy Carbetocin injection

intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy

intramyometrial saline

intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure

Group Type PLACEBO_COMPARATOR

Terlipressin

Intervention Type DRUG

intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy

Interventions

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Terlipressin

intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy

Intervention Type DRUG

Other Intervention Names

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carbitocin

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No