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

NCT05170230 | Recruiting

• 1 other identifier: Elbanna_006
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Myoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin

  24 hours

• 2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time

  12 hours

Study Arms (3)

intracapsular myomectomy Terlipressin injection

ACTIVE COMPARATOR

intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure

Drug: Terlipressin

intracapsular myomectomy Carbetocin injection

ACTIVE COMPARATOR

intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure

Drug: Terlipressin

intramyometrial saline

PLACEBO COMPARATOR

intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure

Drug: Terlipressin

Interventions

Terlipressin DRUG

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

Also known as: carbitocin

intracapsular myomectomy Carbetocin injection; intracapsular myomectomy Terlipressin injection; intramyometrial saline

Eligibility Criteria

• Age: 16 Years - 45 Years
• Gender Eligibility Details: women have multiple myomectomy undergoing laparoscopic myomectomy
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged 16-45 years
• Appropriate medical status for laparoscopic surgery (largest myoma ≤15 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wael Elbanna Clinic: lead

Study Sites (1)

Wael El Banna Clinic

Maadi, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 23498888 BACKGROUND

• 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.

  PMID: 30056355 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Myoma

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Wael El Banna

CONTACT

01227760402; waelelbanna@drwaelelbanna.com

Esraa mohammad

CONTACT

01212421260; esraamoghawry@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 27, 2021
• Study Start: February 27, 2022
• Primary Completion: December 30, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 25, 2024

Record last verified: 2023-10

Locations

EG (1)