Comparing Anterior Prolapse Repair With and Without Allograft Use: A Randomized Control Trial With Long Term Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- 1-Year Recurrent prolapse- anatomic
研究概览
简要总结
This is a randomized control trial comparing anterior colporrhaphy with augmentation with dermal allograft (ARCUS) to anterior colporrhaphy with a suture-based repair (native tissue). Patients were randomized to one treatment and then were followed post-operatively for 7-10 years. Prior to surgery patients had a POPQ vaginal prolapse exam and completed a quality of life questionaire (PFDI). They had a repeat POPQ exam and quality of life questionaires at their post-op operative visits. We compare recurrent prolapse rates between these 2 groups.
详细描述
Objective
To determine whether dermal allograft (ARCUS) reduces anterior prolapse recurrence at 1 and 7-10 years post-operatively. Our central question is whether we can reduce the rate of rate of anterior compartment prolapse recurrence after surgical repair, is the recurrence rate reduced with allograft use, and does this benefit hold up over time?
Methods: Patient will be randomized by computer generated block randomization to native tissue (suture based) anterior colporrhaphy or colporrhaphy with graft (ARCUS) usage. Neither patients nor surgeons will be blinded due to the nature of the surgery. Patients will be followed for 7-10 years post-operatively. Participants will complete a POPQ exam and the PFDI (Pelvic Floor Distress Inventory) questionnaire pre-operatively. Patients will return for a POPQ exam at 1 year post-operatively and complete the PFDI (Pelvic Floor Distress Inventory) and PISQ (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence) questionnaires. Patients will be asked to return to the office for a research visit 7-10 years post-operatively for a POPQ exam and to complete quality of life questionnaires including PFDI 20 (Pelvic floor distress inventory), PISQ-R (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence, Revised), and PGI (Patient global assessment of improvement).
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any patient planning to undergo surgery for anterior compartment prolapse, English speaking.
排除标准
- •Any patient who does not speak English due to standardized English language based questionaires, and patients without anterior compartment prolapse.
研究组 & 干预措施
anterior colporrhaphy with dermal graft
Patients randomized to this arm underwent anterior colporrhaphy with dermal graft augmentation (ARUCS) during their surgery for pelvic organ prolapse.
干预措施: dermal graft (ARCUS repliform) for anterior colporrhaphy (Procedure)
anterior colporrhaphy suture based
Patients randomized to this arm underwent anterior colporrhaphy with suture based repair (native tissue) during their surgery for pelvic organ prolapse. This is and was the most common practice for anterior colporrhaphy.
干预措施: suture based anterior colporrhaphy (Procedure)
结局指标
主要结局
1-Year Recurrent prolapse- anatomic
时间窗: 1 year post-operative
Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater
7-10 Years Recurrent prolapse-anatomic
时间窗: 7-10 years post-operative
Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater
次要结局
- 1 Year composite score(1 year post-operative)
- 7-10 years composite score(7-10 years post-operative)