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临床试验/NCT03901404
NCT03901404已完成不适用

Used During Myomectomy Operation; Comparison of Fundus Incision, Energy Modalities and Methods of Extraction

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Energy Modalities

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients operated with the diagnosis of myoma uteri

排除标准

  • Cardiopulmonary diseases such as cardiac insufficiency, myocardial infarction, unstable angina, acute or new vascular thrombosis, asthma or pulmonary obstructive disease;
  • Patients with long-term Trendelenburg contraindications;
  • Previous pelvic or abdominal radiation therapy; or those with inadequate bone marrow, kidney and hepatic function;
  • Gynecological malignancies.
  • Those who received preoperative medication due to myoma uteri

结局指标

主要结局

Energy Modalities

时间窗: 3 months

In patients undergoing myomectomy, the energy modality used by the surgeon will be recorded to remove the myoma. bipolari, monopolar or ultrasonic

Methods of Extraction

时间窗: 3 months

In patients undergoing myomectomy operation, the method used by the surgeon to remove myoma from the abdomen will be recorded. morselator, vaginally with colpotomi

Fundus Incision

时间窗: 3 months

In patients undergoing myomectomy, the incision used by the surgeon will be recorded to remove myoma. to be recorded as transverse or vertical.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pınar Kadirogulları

principal investigator, M.D, Department of Obstetrics and GynecologyR

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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