Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure
研究概览
简要总结
To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging).
详细描述
Pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective evaluations included Pelvic Organ Prolapse Quantification [POP-Q] staging, preoperative and 1-year postoperative questionnaires were performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy
排除标准
- •malignant diseases
- •unability to understand informed consent
研究组 & 干预措施
patients after hysterectomy
modified anterior transvaginal mesh surgery
干预措施: The Female Sexual Function Index (FSFI) questionnaire (Diagnostic Test)
patients after hysterectomy
modified anterior transvaginal mesh surgery
干预措施: King Health Questionnaire (KHQ) (Diagnostic Test)
patients after hysterectomy
modified anterior transvaginal mesh surgery
干预措施: Pelvic Organ Prolapse Quantification (POPQ) staging (Diagnostic Test)
patients after hysterectomy
modified anterior transvaginal mesh surgery
干预措施: 4-arm polypropylene mesh surgery (Procedure)
patients after hysterectomy
modified anterior transvaginal mesh surgery
干预措施: Postoperative questionnaire (Diagnostic Test)
patients after hysterectomy
modified anterior transvaginal mesh surgery
干预措施: The Short Form Health Survey (SF 36) questionnaire (Diagnostic Test)
结局指标
主要结局
Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure
时间窗: 1 year
assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability
次要结局
- quality of life 1 year after procedure(1 year)
- Sexual function 1 year after procedure(1 year)
- Urinary incontinence 1 year after procedure(1 year)
研究者
Paweł Miotła
Clinical Professor
Medical University of Lublin