Sacrospinous Ligament Fixation vs. Ischial Spine Fasicia Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center, Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 5
- 主要终点
- rate of surgical success
研究概览
简要总结
This trial is designed to investigate the efficacy and safety of two native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients (POP-Q II-IV) and compare the outcome in prolapse women randomized to Sacrospinous ligament fixation (SSLF) and Ischial spinous fascia fixation (ISFF).
详细描述
The population will include Chinese female patients with advanced apical prolapse (stage II-III) and who are undergoing Sacrospinous Ligament Fixation (SSLF) and Ischial spinous fascia fixation (ISFF) procedure using conventional surgical instruments without special instrument. After enrollment, standardized baseline data including demographics, POPQ evaluation, series of validated questionaires via interviews( PFDI-20, PFIQ-7, PISQ-12) will be collected by study personnel at the baseline visit. Eligible consenting patients will proceed to randomizations with equal probability of assignment to SSLF or ISFF. Randomization to either SSLF or ISFF will take place preoperatively by each clinical site using a random permutated block design. After index surgical intervention, scheduled follow-up will occur at 3, 6, 12, 24 and 36 months after the index surgery. At the follow-up visits, POPQ examination will be performed and an update of current medications, an assessment of new or continuing pelvic floor disorders, adverse events that occurred since the previous evaluation, and an assessment of health care costs. A series of validated instruments will be administered via interviews to including PFDI-20, PFIQ-7, PISQ-12, PGI-C.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV)
- •SSLF or ISFF is proceeded as described before，while ancillary procedures like vaginal hysterectomy, anterior/posterior vaginal wall repair without mesh or mid-urethral suspension could be performed simultaneously.
- •Women who have been eligible for long-term follow-up.
- •Women who agreed to participate in the study and signed informed consent.
排除标准
- •Women who have surgical history for prolapse with mesh.
- •Women who have contraindication for surgical procedure
- •Women who are unable to comply with the study procedures
结局指标
主要结局
rate of surgical success
时间窗: up to 36 months after operation
definition for surgical success is symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire. There is no need of further treatment for prolapse, such as reoperation or pessary.
次要结局
- rate of Postoperative recurrence(from 3 months after operation up to 36 months after operation)
- visual analogue scales(up to 36 months after operation, usuallly within 3 days after operation)
- changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7)(up to 36 months after operation)
- changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20)(up to 36 months after operation)
- changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12)(up to 36 months after operation)
- results of postoperative symptomatic improvement using patient global impression of change (PGI-C)(up to 36 months after operation)
- intraoperative and post operative complications(up to 36 months after operation)
研究者
zhulan
Professor
Peking Union Medical College Hospital