The Diagnostic Value Of International Ovarian Tumour Analysis (IOTA) Simple Rules Versus the Pattern Recognition Method In Differentiating Between Malignant And Benign Adnexal Masses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 2
- 主要终点
- comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses
研究概览
简要总结
To compare between the efficacy of IOTA simple rules and pattern recognition method in the differentiating between benign and malignant adnexal masses
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Level-II Transvaginal ultrasonography will be done by the principle investigator (who is unaware about the recognition pattern method) to confirm the presence of the ovarian mass and measure its size and to apply the IOTA simple rules on it (complimentary transabdominal ultrasound might be done for huge pelvi-abdominal masses originating from the ovary).
Level-III ultrasound will be done by expert ultrasound operator (who is blinded to the results of IOTA simple rules assessment of the examined mass) to classify the mass (either benign or malignant) using the pattern recognition method.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ovarian mass more than 5 cm in size (confirmed by transvaginal or transabdominal ultrasonography in gynecology clinic)
- •The patient is candidate for abdominal exploration for ovarian Cystectomy or oophorectomy.
排除标准
- •Complicated ovarian masses.
- •Unfit for surgery.
研究组 & 干预措施
Participants
- Level-II Transvaginal ultrasonography will be done by the principle investigator (who is unaware about the recognition pattern method) to confirm the presence of the ovarian mass and measure its size and to apply the IOTA simple rules on it (complimentary transabdominal ultrasound might be done for huge pelvi-abdominal masses originating from the ovary).
- Level-III ultrasound will be done by expert ultrasound operator (who is blinded to the results of IOTA simple rules assessment of the examined mass) to classify the mass (either benign or malignant) using the pattern recognition method.
- Plan of management for each patient will be based solely on the findings of pattern recognition and the patient's wishes.
- Exploratory laparotomy for excision of the ovarian mass either by ovarian Cystectomy or oophorectomy.
- All specimens will be examined histopathologically.
干预措施: Transvaginal ultrasonography (Device)
结局指标
主要结局
comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses
时间窗: 12 month
次要结局
未报告次要终点
研究者
Dina Mohamed Refaat Dakhly
Assistant Professor Obstetrics and Gynecology
Woman's Health University Hospital, Egypt