The BIO RAMP Trial - BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Number of participants with fistula recurrence
研究概览
简要总结
The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complex cryptoglandular transsphincteric anal fistula undergoing surgical repair by LIFT or advancement flap procedure
- •English or Spanish speaking and capable of providing informed consent
- •Willing to undergo temporary anal seton drainage for requisite time prior to repair
- •Participating surgeons will only be eligible if they perform at least 3 repair procedures/year
排除标准
- •Unable to reliably complete follow up for 12 months postoperatively
- •Primary platelet disorders
- •Thrombocytopenia < 150 plt/microliter
- •Inability to stop anti-platelet agent > 5 days preoperatively
- •Fistula associated with inflammatory bowel disease (IBD), malignancy or pelvic/perineal radiation
结局指标
主要结局
Number of participants with fistula recurrence
时间窗: upto 6 months after surgery
A fistula recurrence is defined as one or more of the following clinical signs or symptoms after repair: recurrent abscess at the site of repair, chronic drainage or passage of flatus from an external opening of the perineum away from the anal verge, a non-healing external opening that tracks toward anus by probing with fistula probe.
Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire
时间窗: Baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.
This instrument queries subjects on health status related to mobility, self-care, 'usual' activities, pain/discomfort, and anxiety/depression with 5 potential responses ranging from "no problems" to inability to complete the task or extreme levels of pain/depression, correlating to a discrete index score from 1-5, a higher number indicating a worse outcome.The instrument also includes an overall VAS self-rating of health ranging from 0-100, higher number indicating better health.
次要结局
- Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool(Baseline, 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery and 12 months after surgery)
- Number of participants who have post operative pain as assessed by the visual analog scale (VAS)(14 days after surgery)
- The relative cost utility of the different treatment strategies as assessed by a questionnaire(12 months after surgery)
研究者
Jeff Van Eps, MD
Assistant Professor
The University of Texas Health Science Center, Houston