Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina
研究概览
简要总结
As the surgical treatment of posterior deep endometriosis may be challenging for surgeons and carry significant risks for patients, preoperative assessment of the location, characteristics and presence of nodules of posterior deep endometriosis is important in order to inform the patient about the various treatment possibilities and to allow adequate counseling regarding treatment strategy. The aim of this study is to investigate the accuracy of rectal water-contrast transvaginal ultrasonography (RWC-TVS), and sonovaginography (SVG) in patients with clinical suspicion of posterior deep endometriosis (DIE).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis
排除标准
- •previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography)
- •previous surgical diagnosis of posterior deep infiltrating endometriosis
结局指标
主要结局
Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina
时间窗: At maximum 6 months before undergoing laparoscopic surgical approach
次要结局
- Accuracy in estimating the largest diameter of endometriosis nodules in the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina(At maximum 6 months before undergoing laparoscopic surgical approach)
- Accuracy in estimating the deep of infiltration in the intestinal muscolari propria of nodules of rectosigmoid endometriosis(At maximum 6 months before undergoing laparoscopic surgical approach)
- Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge(At maximum 6 months before undergoing laparoscopic surgical approach)
- Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis(At maximum 6 months before undergoing laparoscopic surgical approach)
研究者
Fabio Barra
MD
Ospedale Policlinico San Martino