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

NCT05266534 | Recruiting

• 1 other identifier: Elbanna_008
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Myoma

Outcome Measures

Primary Outcomes (1)

• To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets

  the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets

  12 hours

Secondary Outcomes (3)

• To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets

  24 hours

• To measure the operative time in each group without using haemostatic tourniquets

  24 hours

• to assess the measure the severity of pain using VAS score

  24 hours

Study Arms (3)

intramyometrial Terlipressin injection in women undergoing open myomectomy

ACTIVE COMPARATOR

intramyometrial Terlipressin injection

Drug: Terlipressin

intramyometrial Carbetocin injection in women undergoing open myomectomy

ACTIVE COMPARATOR

intramyometrial Carbetocin injection

Drug: Carbetocin

intramyometrial saline injection in women undergoing open myomectomy procedure

PLACEBO COMPARATOR

intramyometrial saline injection in women

Drug: Saline

Interventions

Terlipressin DRUG

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

Also known as: glypressin

intramyometrial Terlipressin injection in women undergoing open myomectomy

Carbetocin DRUG

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

Also known as: pabal

intramyometrial Carbetocin injection in women undergoing open myomectomy

Saline DRUG

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

Also known as: NaCl 0.9

intramyometrial saline injection in women undergoing open myomectomy procedure

Eligibility Criteria

• Age: 16 Years - 40 Years
• Gender Eligibility Details: women with utrine fibroids
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wael Elbanna Clinic: lead

Study Sites (1)

Wael El Banna Clinic

Maadi, Egypt

RECRUITING

Related Publications (1)

• 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. No abstract available.

  PMID: 28826956 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Myoma

Interventions

Terlipressin; carbetocin; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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
• Masking Details: Double Blinded Randomized Placebo-Controlled Trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double Blinded Randomized Placebo-Controlled Trial

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: March 4, 2022
• Study Start: December 30, 2021
• Primary Completion: June 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 4, 2022

Record last verified: 2021-12

Locations

EG (1)