Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Vaginal axis
研究概览
简要总结
Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the procedure. Recent years have witnessed a proliferation of inquiries appraising the efficacy of laparoscopic lateral suspension, pectopexy, and sacrospinous ligament fixation interventions, which have, over time, garnered extensive clinical application, in relation to recurrence rates. A multitude of investigations have been undertaken to delineate the optimal vaginal axis. In the present investigation, we have delineated a research protocol aimed at scrutinizing these alternative surgical modalities with regard to their impact on the vaginal axis.
详细描述
The study objective pertains to the assessment of vaginal axis in patients undergoing apical prolapse surgery, whether they have undergone hysterectomy or not. The investigation is designed to test the null hypothesis by means of a comparative analysis of preoperative and postoperative Magnetic Resonance Imaging images capturing the vaginal axis. This examination will be conducted on patients slated to receive lateral mesh suspension, pectopexy, and sacrospinous ligament fixation procedures for the correction of apical prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with genital prolapse
排除标准
- •Patients who had pouch of Douglas obliteration
- •Patients with enterocele
- •Patients who have any congenital or acquired anatomic and reproductive anomaly
结局指标
主要结局
Vaginal axis
时间窗: at 4th months after the operation
From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.
Vaginal distances
时间窗: at 4th months after the operation
The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.
次要结局
- Prolapse symptoms, Colorectal-Anal Impact Questionnaire(at 4th months after the operation)
- Prolapse symptoms(at 4th months after the operation)
- Quality of life measures(at 4th months after the operation)
- Urinary Symptoms(at 4th months after the operation)
- Postoperative de novo dyspareunia(at 4th months after the operation)
- Sexual functions(at 4th months after the operation)
- Patient Global Impression of Improvement (PGI-I)(at 4th months after the operation)
研究者
fatih sahin
Principal Investigator, MD
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization