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Myoma clinical trials

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NCT ID: NCT05806307 Recruiting - Clinical trials for Blood Loss, Surgical

Methods Decreasing Bleeding in Open Myomectomy

Start date: March 15, 2023
Phase: Phase 4
Study type: Interventional

Uterine leiomyomas (fibroids or myomas) are benign, smooth muscle tumors of the human uterus. Most myomas are asymptomatic (symptomless) and are discovered incidentally during a routine pelvic examination or imaging studies and have a lifetime incidence of approximately 70% in the general population . However, Approximately 20-40% of women with fibroids experience significant symptoms and consult gynecologic care. The most common clinical symptoms include abnormal uterine bleeding, dysmenorrhea, pelvic pain, infertility, and recurrent pregnancy loss The standard treatment of symptomatic leiomyomas is Abdominal myomectomy Blood loss during myomectomy can be intra-operative or postoperative and with hematoma formation. The average volume of blood loss during abdominal myomectomy is 200 to 800 ml. massive blood loss associated with the dissection of huge fibroids renders myomectomy a more technically challenging procedure than hysterectomy. Sometimes myomectomy is converted to hysterectomy intra-operatively when bleeding becomes heavy and uncontrollable or when it is impossible to reconstruct the uterus because of the many defects left by removal of multiple myomas . Many techniques are used to reduce blood loss during myomectomy; preoperative measures such as correction of preoperative anemia associated with menorrhagia may be treated with iron supplementation, use of gonadotropin (GHG) triggers prior to surgery. Intra-operative measures as use of tourniquet around the uterus during the operation, injections of Vasopressin or other vasopressors as epinephrine in the uterine muscle and use of ecbolic (misoprostol, oxytocin, and carbetocin etc.). Uterine artery ligation, embolization, or internal iliac artery ligation may also be used to avoid hysterectomy when heavy bleeding is anticipated or occurs during myomectomy

NCT ID: NCT05683041 Recruiting - Myoma Clinical Trials

Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

PALLM
Start date: February 22, 2023
Phase: N/A
Study type: Interventional

Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy. Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.

NCT ID: NCT05266534 Recruiting - Myoma Clinical Trials

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

myomectomy
Start date: December 30, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05242783 Recruiting - Myoma Clinical Trials

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

the study aims to evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing abdominal 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.

NCT ID: NCT05170230 Recruiting - Myoma Clinical Trials

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

Start date: February 27, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04748978 Recruiting - Uterine Fibroid Clinical Trials

OPPIuM Technique and Myolysis With Diode Laser Dwls

Myolysis
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

PURPOSE OF THE STUDY The study aims to examine the feasibility and effectiveness of the OPPIuM technique combined with myolysis using the DWLS diode laser. In addition, to evaluate the reduction of myoma volume and the extent of uterine bleeding with myolysis to improve women's quality of life and avoid resectoscope hysteroscopy for a G2 MIOMA, which may lead to an increase in intraoperative surgical risks and long-term complications. POPULATION 35 patients aged between 18 and 48 years with clinical and/or ultrasound diagnosis of uterine fibromatosis, belonging to the Endometriosis/Pelvic Chronic Pain Centre of the Complex Operating Unit of Gynecology of the University Polyclinic of Monserrato and other centers involved in the study. To be eligible for inclusion, patients with ultrasound and hysteroscopic diagnosis of a single submucosal myoma, partially intramural (G1 or G2) ≤ 3 cm, must present symptoms such as abnormal uterine bleeding and pelvic pain, for which surgical treatment was scheduled. INCLUSION CRITERIA - Women between 18 and 48 years old - Diagnosis of symptomatic uterine fibromatosis (abnormal uterine bleeding and/or pelvic pain) with single fibroma ≤ 3 cm G1 or G2. EXCLUSION CRITERIA Patients who cannot provide written informed consent or follow the procedures set out in the protocol. - Patients with malignant neoplasms or serious systemic diseases - Patients with multiple fibroids or single > 3 cm - Asymptomatic patients - Patients with other uterine or related diseases - Patients seeking a pregnancy. INTERVENTION STRATEGY AND INSTRUMENTS A total of 35 women will initially be included in the study, of which: Patients will undergo the following assessments: - Collection of physiological, pathological, and pharmacological anamnesis - Collection of diagnostic tests (ultrasound) and staging of the underlying disease (uterine fibromatosis) - Completion of the PBAC questionnaire - Transvaginal ultrasound - Office diagnostic hysteroscopy with OPPIuM and Myolysis - Possible resectoscope hysteroscopy or laser myomectomy in narcosis.

NCT ID: NCT04400942 Recruiting - Uterine Fibroids Clinical Trials

Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

Start date: January 1, 2015
Phase:
Study type: Observational

The aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram. This tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy.

NCT ID: NCT03880604 Recruiting - Myoma Clinical Trials

Triple Tourniquets With or Without Tranexamic Acid for Reducing Blood Loss at Open Myomectomy

TTT
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

In this study, the investigators will investigate the effectiveness of an intravenous tranexamic acid plus triple tourniquets compared with triple tourniquets alone for the reduction of blood loss at the time of myomectomy

NCT ID: NCT03880045 Recruiting - Myoma Clinical Trials

Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy

NCT ID: NCT03550703 Recruiting - Leiomyoma Clinical Trials

Open Label Immunotherapy of Myoma

V3-myoma
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.