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

• Sponsor: Wael Elbanna Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05170230
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 52
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myoma	Drug: Terlipressin	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model 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 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.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 siteThe 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.
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial
• Actual Study Start Date: Feb 27, 2022
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy [12 hours]

   measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy

Secondary Outcome Measures

1. 1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin [24 hours]

   compare the hemoglobin level before and after operation after intracapsular injection of Terlipressin versus Carbetocin saline as aplacebo in women undergoing laparoscopic myomectomy

2. 2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time [12 hours]

   2. To measure the operative time in minutes after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wael El Banna Clinic	Maadi		Egypt

Sponsors and Collaborators

• Wael Elbanna Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• 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.
• 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.

• Responsible Party: Wael Elbanna Clinic
• ClinicalTrials.gov Identifier: NCT05170230
• Other Study ID Numbers: Elbanna_006
• First Posted: Dec 27, 2021
• Last Update Posted: May 2, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhage; Terlipressin

Study Results

No Results Posted as of May 2, 2022