A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- objective success
研究概览
简要总结
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
详细描述
Investigational intervention：SSLF or ISFF operations
Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
Principal Investigator：Chang Ren, M.D., Department of Obstetrics & Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Study subjects：Adult patients with symptomatic stage II~IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion.
Study objectives：The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age≤65 years, for those scheduled to receive hysterectomy age≥40 years
- •patients with symptomatic stage II~IV uterine or vaginal vault prolapse
- •receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital
排除标准
- •plans to live abroad within follow-up span
- •contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations
- •patients with hip joint problem who could not pose a lithotomy position
研究组 & 干预措施
sacrospinous ligament fixation group
The patients will receive sacrospinous ligament fixation operation.
干预措施: sacrospinous ligament fixation (Procedure)
ischial spine fascia fixation group
The patients will receive ischial spine fascia fixation operation.
干预措施: ischial spine fascia fixation (Procedure)
结局指标
主要结局
objective success
时间窗: 3 months after operation
no prolapse, stage I or only asymptomatic stage II prolapse
次要结局
- Pelvic Floor Distress Inventory-20 (PFDI-20)(Change from Baseline in PFDI-20 at 3 months and 1 year)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)(Change from Baseline in PISQ-12 at 3 months and 1 year)
- complications(through study completion, an average of 1 year)
- subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved)(1 year after operation)
- Pelvic Floor Impact Questionnaire-7 (PFIQ-7)(Change from Baseline in PFIQ-7 at 3 months and 1 year)
- recurrence rate(3 months after operation)