Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Recurrent Stage II or Greater Anterior Vaginal Prolapse
研究概览
简要总结
The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.
详细描述
Successful correction of anterior vaginal prolapse remains one of the most challenging aspects of pelvic reconstructive surgery. Up to 70% have recurrent prolapse following anterior colporrhaphy. The low success rate has consequently led to widespread use of grafts in anterior vaginal prolapse repair. While both biologic grafts and polyglactin 910 mesh have yielded disappointing results, uncontrolled studies have demonstrated low recurrence rates with polypropylene mesh reinforcement.
The Perigee Transobturator Prolapse Repair System (Perigee TPRS) (American Medical Systems, Minnetonka, Minnesota) is used to repair anterior vaginal prolapse via a transobturator approach. Specially-designed helical needles are utilized to attach either a porcine dermal (InteXenTM) or soft polypropylene (InteProTM) graft to the pelvic sidewall at four points. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the Perigee TPRS with polypropylene mesh to that of anterior colporrhaphy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •stage II or greater anterior vaginal prolapse requiring surgical correction
- •age 21 years and older
排除标准
- •less than Stage II anterior vaginal prolapse
- •decline participation
- •pregnant or contemplating future pregnancy
- •prior anterior vaginal prolapse repair with biologic or synthetic graft
- •active or latent systemic infection
- •compromised immune system
- •previous pelvic irradiation or cancer
- •known hypersensitivity to polypropylene
- •uncontrolled diabetes mellitus
- •unable or unwilling to give valid informed consent
- •unable or unwilling to comply with the protocol
- •scheduled to undergo concomitant Burch colposuspension or pubovaginal sling
结局指标
主要结局
Recurrent Stage II or Greater Anterior Vaginal Prolapse
时间窗: three years
Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.
次要结局
- Operative Time(perioperative)
- Vaginal Mesh Exposure(perioperative)