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

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.

Study Overview

• Status: Recruiting
• Conditions: Myoma
• Intervention / Treatment: Drug: Terlipressin

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wael El Banna; Phone Number: 01227760402; Email: waelelbanna@drwaelelbanna.com
• Study Contact Backup: Name: Esraa mohammad; Phone Number: 01212421260; Email: esraamoghawry@gmail.com

Study Locations

• Egypt
  • Maadi, Egypt
    • Recruiting
    • Wael El Banna Clinic
    • Contact: Wael Elbanna; Phone Number: 01227760402; Email: waelelbanna@drwaelelbanna.com
    • Contact: esraa moghawry; Phone Number: 01212421260; Email: esraamoghawry@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intracapsular myomectomy Terlipressin injection; intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure	Drug: Terlipressin; intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy; Other Names: carbitocin
Active Comparator: intracapsular myomectomy Carbetocin injection; intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure	Drug: Terlipressin; intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy; Other Names: carbitocin
Placebo Comparator: intramyometrial saline; intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure	Drug: Terlipressin; intracapsular injection of Terlipressin versus Carbetocin for decreasing blood loss in women undergoing laparoscopic myomectomy; Other Names: carbitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy	measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin	compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy	24 hours
2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time	2. To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy	12 hours

Collaborators and Investigators

• Sponsor: Wael Elbanna Clinic

Publications and helpful links

General Publications

• Srivastava S, Mahey R, Kachhawa G, Bhatla N, Upadhyay AD, Kriplani A. Comparison of intramyometrial vasopressin plus rectal misoprostol with intramyometrial vasopressin alone to decrease blood loss during laparoscopic myomectomy: Randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:279-283. doi: 10.1016/j.ejogrb.2018.07.006. Epub 2018 Jul 5.
• Marsh EE, Ekpo GE, Cardozo ER, Brocks M, Dune T, Cohen LS. Racial differences in fibroid prevalence and ultrasound findings in asymptomatic young women (18-30 years old): a pilot study. Fertil Steril. 2013 Jun;99(7):1951-7. doi: 10.1016/j.fertnstert.2013.02.017. Epub 2013 Mar 15.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Antihypertensive Agents; Vasoconstrictor Agents; Terlipressin
• Other Study ID Numbers: Elbanna_006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No