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NCT ID: NCT06150521 Active, not recruiting - Clinical trials for Hysteroscopic Myomectomy

Hysteroscopic Myomectomy for Submucosal Myomas Without Energy Instruments

Start date: May 23, 2023
Phase:
Study type: Observational

Uterine fibroid are the most common benign tumor in the female reproductive system. Although many patients with uterine fibroid do not need to be treated because they are asymptomatic, some patients can experience compression, menorrhagia, pain, irregular bleeding or infertility. The symptoms caused by uterine fibroid are related to its location and size. Submucous fibroids constitute 5-10% of all uterine fibroids.The submucous hysteromyoma is the most likely to cause symptoms, often leads to menorrhagia, irregular bleeding or infertility. Hysteroscopic myomectomy is a commonly used minimally invasive procedure. The submucous myoma can be resected out by endoscopic resectoscope with electricloop (unipolar and bipolar) . It can preserve the uterus and fertility, also effectively alleviate symptoms. However, some specific complications have also followed,such as: hemorrhage,uterine perforation, pneumonedema,infections,adhesions,etc. Uterine perforation occurs when the electrode is working, there is a high risk of injury to adjacent anatomical structures. And even without perforation, sometimes thermal injury to adjacent organs may still be discovered in a few days after surgery.In addition,Many scholars have found that hysteroscopic electromyectomy has a higher risk of intrauterine adhesion than other intrauterine operations. In order to reduce the damage caused by energy source, especially the adverse effects of thermal damage on the endometrium, the new methods of hysteroscopic myomectomy currently include: the hysteroscopic tissue removal (HTR) system, the cold loop myomectomy, the Hysteroscopy Endo Operative system (HEOS),etc. Existing studies show that,These manipulation techniques did not cause the myometrium damage by radiofrequency energy source, greatly reducing the risk of postoperative intrauterine adhesions. The cold knife hysteroscopic myomectomy in this study is a series of procedures using cold instruments(mechanically, with scissor, grasping or morcellation) to remove uterine submucosal fibroids. The purpose of this surgical technique is to make the operation safe and effective, with greater emphasis on the anatomical and physiological integrity of the myometrial and endometrial layers. This study aims to evaluate the safety and efficacy of cold knife hysteroscopic myomectomy.

NCT ID: NCT05925153 Completed - Myoma Clinical Trials

Vision Screening Study for College Students at Nankai University

Start date: September 1, 2022
Phase:
Study type: Observational

The prevalence of myopia among high school students in China is as high as 80%-90%. For college students with longer years of education, the majority of myopia and the factors influencing the prevalence of high myopia should be better understood for timely prevention and treatment. This study aims to investigate the prevalence of myopia and education-related influencing factors among college students at Nankai University.

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: NCT04983719 Completed - Myoma Clinical Trials

Transcervical Myoma Biopsy Video

TMBV
Start date: January 1, 2021
Phase:
Study type: Observational

To describe the fertility-sparing management of an atypical uterine myoma. Step-by-step video explanation of transcervical biopsy using transabdominal ultrasound guidance, highlighting tips and tricks. Patient consent was obtained for publication of the case.

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: NCT04694677 Not yet recruiting - Myoma Clinical Trials

Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.

Start date: January 10, 2021
Phase: N/A
Study type: Interventional

Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of women in the reproductive age group