myomectomy: The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets

Sponsor

Wael Elbanna Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05266534

Collaborator

(none)

162

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.

Condition or Disease	Intervention/Treatment	Phase
Myoma	Drug: Terlipressin Drug: Carbetocin Drug: Saline	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 Terlipressin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets 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 computergenerated randomization table with a 1:1:1 group allocation

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double Blinded Randomized Placebo-Controlled TrialDouble Blinded Randomized Placebo-Controlled Trial

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Double Blinded Randomized Placebo-Controlled Trial

Primary Purpose:

Treatment

Official Title:

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.

Actual Study Start Date :

Dec 30, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intramyometrial Terlipressin injection in women undergoing open myomectomy intramyometrial Terlipressin injection	Drug: Terlipressin the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy Other Names: glypressin
Active Comparator: intramyometrial Carbetocin injection in women undergoing open myomectomy intramyometrial Carbetocin injection	Drug: Carbetocin the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy Other Names: pabal
Placebo Comparator: intramyometrial saline injection in women undergoing open myomectomy procedure intramyometrial saline injection in women	Drug: Saline the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy Other Names: NaCl 0.9

Arm

Intervention/Treatment

Active Comparator: intramyometrial Terlipressin injection in women undergoing open myomectomy

intramyometrial Terlipressin injection

Drug: Terlipressin

the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Other Names:

glypressin

Active Comparator: intramyometrial Carbetocin injection in women undergoing open myomectomy

intramyometrial Carbetocin injection

Drug: Carbetocin

the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Other Names:

pabal

Placebo Comparator: intramyometrial saline injection in women undergoing open myomectomy procedure

intramyometrial saline injection in women

Drug: Saline

the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy

Other Names:

NaCl 0.9

Outcome Measures

Primary Outcome Measures

To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets [12 hours]
the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets

Secondary Outcome Measures

To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets [24 hours]
To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets
To measure the operative time in each group without using haemostatic tourniquets [24 hours]
To measure the operative time in each group without using haemostatic tourniquets
to assess the measure the severity of pain using VAS score [24 hours]
post operative pain VAS score

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteri

Women aged 16-45 yearsAppropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 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 Criteria

Open myomectomy using mechanical tourniquet
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

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

Parker WH, Berek JS, Pritts EA, Olive D, Chalas E, Clarke-Pearson D. Regarding "Incidence of Occult Uterine Malignancy Following Vaginal Hysterectomy with Morcellation". J Minim Invasive Gynecol. 2018 Jan;25(1):187-188. doi: 10.1016/j.jmig.2017.07.027. Epub 2017 Aug 18.

Responsible Party:

Wael Elbanna Clinic

ClinicalTrials.gov Identifier:

NCT05266534

Other Study ID Numbers:

Elbanna_008

First Posted:

Mar 4, 2022

Last Update Posted:

Mar 4, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemorrhage

Terlipressin

Carbetocin

Study Results

No Results Posted as of Mar 4, 2022