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Myoma;Uterus clinical trials

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NCT ID: NCT05811286 Completed - Myoma;Uterus Clinical Trials

The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study

Start date: May 20, 2021
Phase: N/A
Study type: Interventional

Polyps, intracavitary myomas and retained products of conception (RPOC) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. In general, intracavitary lesions are treated by operative hysteroscopy with bipolar resectoscopic removal under general anaesthesia, performed in the theatre (OR). Potential problems with this approach are thermal damage and impairment of visibility due to loose tissue fragments necessitating multiple entries for tissue removal. Recently, lesion morcellation by hysteroscopy has been introduced as an alternative technique. Compared to the resectoscopic approach, morcellation is reportedly associated with a shorter total procedure time, smaller fluid deficit and number of insertions. A few trials also registered a higher success rate in completeness of resection. No significant differences in odds of surgical complications have been reported. Most hysteroscopic morcellators have diameters up to 8 mm, for which cervical dilation under general anaesthesia is usually needed. Recently, companies have developed hysteroscopic morcellators with smaller diameters, e.g. 6.3 mm for the 19 Fr. intrauterine BIGATTI Shaver (IBS®). This means less need for cervical dilation, and potential use without anesthesia. At this moment, there are no prospective studies available on feasibility of the 19 Fr. intrauterine BIGATTI Shaver (IBS®). Before implementing hysteroscopic morcellation in our department, we need a feasibility study assessing the method in standard conditions in the operation room or in ambulatory setting under sedation. Trial objectives: Assessment of the feasibility of hysteroscopic morcellation of benign uterine intracavitary lesions. The primary objective is to assess the completeness of hysteroscopic resection in patients undergoing the procedure under general anesthesia or sedation. Secondary objectives are to assess perioperative parameters as operation time, need for cervical dilation, adverse events, pain, operator satisfaction; to assess quality of tissue for histological examination; to assess postoperative complications and pain.

NCT ID: NCT05761418 Completed - Myoma;Uterus Clinical Trials

Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Start date: March 1, 2018
Phase: Phase 3
Study type: Interventional

Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy

NCT ID: NCT05025410 Completed - Myoma;Uterus Clinical Trials

Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

Start date: November 1, 2021
Phase:
Study type: Observational

Remimazolam is a novel drug approved for induction and maintenance of general anesthesia. This study aims to check the appropriate dose and patient response by administering remimazolam and remifentanil in surgery that does not require a neuromuscular blocking agents.

NCT ID: NCT04482959 Completed - Myoma;Uterus Clinical Trials

Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy

Start date: July 15, 2020
Phase: Phase 4
Study type: Interventional

Submucous myomas represent one of the main indications of operative hysteroscopy. Since 1976 when Neuwirth and Amin reported the first five cases of excision of submucous myomas , several techniques have been developed in order to render hysteroscopic myomectomy a safe and effective procedure . Hysteroscopic myomectomy is currently considered the "gold standard" minimally invasive approach for the treatment of symptomatic submucous myomas . Patients undergoing hysteroscopic myomectomy are liable to significant blood loss, and hemodynamic and hematological disturbances. Excessive bleeding during hysteroscopic myomectomy remains a major challenge for the endoscopic gynecological surgeons. Many interventions were introduced to reduce the risk of bleeding during myomectomy. These include the use of utero-tonics such as oxytocin, or the use of anti-fibrinolytics such as tranexamic acid . The potential advantage of oxytocin infusion during hysteroscopic myomectomy is that it can maintains uterine contractility throughout the procedure, and thus, reduce blood loss . Carbetocin (1-deamino-1-monocarba-(0-2-methyltyrosine)-oxytocin) is a long-acting synthetic agonist analogue of the human oxytocin. When injected to a woman, it induces uterine contractions . Although many interventions have been described to reduce the intraoperative blood loss during hysteroscopic myomectomy, there is a need for a well-designed randomized controlled trials to identify the most efficient interventions, with reasonable safety profiles, to help the perform a safe and curative surgery.

NCT ID: NCT03901404 Completed - Surgery Clinical Trials

Myomectomy Operation and Fundus Incision, Energy Modalities and Methods of Extraction

Start date: April 1, 2019
Phase:
Study type: Observational

Myomectomy operation due to myoma uteri is an operation that can cause serious blood loss. For some anatomical reasons, fundal myomas were removed, while a group of investigators recommended the initiation of a longitudinal incision and some surgeons preferred a transverse incision. the authors aim to show some surgical differences, intraoperative blood loss, and difficulties and ease of removal of myoma in patients with these approaches without consensus. It is also noted that the incision made with the same energy modality is recorded; The effect of energy modality on blood loss and surgical comfort will be examined. Different approaches are used for laparoscopic surgical operations in order to remove myoma from the abdomen. It can be removed from the vagina by colpotomy and can also be minimized in the abdomen by a morselator. In particular, patients with vaginal myoma removed, such as complaints of postoperative dyspareunia will be followed. In this way, the investigators aim to evaluate the methods which have not yet gained clarity in the literature or have not proven superiority to each other.

NCT ID: NCT03871868 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D Levels And Myoma Uteri

Start date: December 1, 2018
Phase:
Study type: Observational

Women with at least one uterine leiomyoma and polycystic ovary syndrome over 10 mm and women with normal ultrasonographic findings were included in the study. Blood samples were taken for biochemical analysis such as vitamin D, calcium, magnesium, phosphorus, thyroid stimulating hormone (TSH), hemoglobin (hb), hematocrit (htc), platelet (plt), and albumin. The study groups were compared in terms of these biochemical markers and family history of patients, daily sunshine hours, clothing preferences and education level.

NCT ID: NCT03533907 Completed - Infertility, Female Clinical Trials

Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Start date: November 1, 2013
Phase:
Study type: Observational

The investigators analyzed a group of infertile women treated with Ulipristal Acetate (UA) for uterine fibroids at the Humanitas Fertility Center. All the patients' data were extracted from the Fertility Center external-audit-anonymized electronic research query system.

NCT ID: NCT03009812 Completed - Myoma;Uterus Clinical Trials

Transverse vs Longitudinal Incision in Myomectomy

Start date: January 2017
Phase: N/A
Study type: Interventional

The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.