One-year Outcomes of an Innovative Laparoscopic Pectopexy Procedure Using Inverted T-mesh for Treatment of Advanced Uterine and Anterior Vaginal Prolapse.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Pelvic Organ Prolapse Anatomical Outcome
研究概览
简要总结
Patients referred for pelvic reconstructive surgery frequently present with combined anterior and apical vaginal wall prolapse. Previous studies found that anterior compartment involvement is the most common and serious defect that occurs with an apical defect. To address this, many surgeons will conduct concomitant surgeries in addition to sacrocolpopexy or pectopexy. This prospective pilot study was conducted to explore the surgical outcomes and safety of an innovative laparoscopic uterine pectopexy technique using inverted T-meshes for simultaneous apical and anterior vaginal repair.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presentation with a symptomatic uterine prolapse ≧ POP-Q stage 2 in patients who wished to retain the uterus
排除标准
- •No known uterine or cervical pathology, no previous prolapse mesh repair, and no diseases known to affect bladder or bowel function
研究组 & 干预措施
Pectopexy
Laparoscopic pectopexy with inverted T-mesh for concomitant anterior and apical vaginal prolapse repair
干预措施: Laparoscopic pectopexy (Procedure)
Sacrocolpopexy
Laparoscopic sacrocolpopexy with double mesh for pelvic organ prolapse repair
干预措施: Laparoscopic sacrocolpopexy (Procedure)
结局指标
主要结局
Pelvic Organ Prolapse Anatomical Outcome
时间窗: 1 year post-operation
Anatomic outcomes were assessed by evaluating the pre- and post-operative prolapse stages as evaluated by the Pelvic Organ Prolapse Quantification (POP-Q) system. The plane of the hymen was defined as zero, all measures are in centimeters proximal (negative number) and distal (positive number) to the hymen. The more positive the number, the more severe the prolapse.
Rate of distress caused by pelvic floor symptoms
时间窗: 1 year post-operation
These outcomes were assessed pre- and post-operation via the Pelvic Floor Distress Inventory (PFDI-20) questionnaire. Higher scores indicated greater symptom distress.
次要结局
- Rate of surgical complications(1 year post-operation)
- Rate of Reoperations(1 year post-operation)
研究者
Man-Jung Hung
Director, Division of Gynecological Minimally Invasive Therapy
Chung Shan Medical University