SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 646
- 试验地点
- 41
- 主要终点
- Percentage of Participants who Achieve Clinical Remission of Fistula
研究概览
简要总结
In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice.
The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions.
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
详细描述
This is a non-interventional, prospective study of participants with complex fistulizing conditions (CPF-CD, CD develops CD-RVF and CCF) who are currently undergoing surgical intervention in the real world clinical setting.
The study will enroll approximately 750 participants. The data will be collected prospectively at the study sites and will be recorded into electronic data capture forms (EDCs). Participants will be enrolled to the following observational cohorts:
- Participants With CPF-CD
- Participants With CD-RVF
- Participants With CCF
This multi-center study will be conducted in the United States, Canada, Europe, and Israel. Participants undergoing surgical interventions to treat fistulas will be enrolled from surgical and gastrointestinal (GI) specialty sites. The overall duration of the study will be 24 months. Data will be collected at baseline with follow-up information collected approximately every 3 to 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants with CPF-CD
- •CPF-CD that meets one or more of the following criteria:
- •High inter-sphincteric, high trans-sphincteric, extra-sphincteric or supra-sphincteric fistula, or
- •Presence of greater than or equal to (>=) 2 external openings, or
- •Associated perianal abscess(es)
- •Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
- •Fistulotomy, fistula plug, fibrin glue, advancement flap (AF), ligation of inter-sphincteric fistula tract (LIFT), flap repair, fistulectomy, proctectomy, stem cell therapy, other; and seton for palliative purposes.
- •Participants with CD-RVF: Rectovaginal fistula per physician diagnosis
- •1. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
- •Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy, proctectomy, stem cell therapy, gracilis muscle interposition/tissue grafts, martius procedure, abdominal procedures, other; and seton use for palliative purposes.
- •Participants with CCF:
- •Complex cryptoglandular fistula that meets one or more of the following criteria:
- •Mid or high trans-sphincteric, or
- •Anterior in women, or
- •Horseshoe fistula
- •Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
- •Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy, proctectomy, stem cell therapy, other; and seton use for palliative purposes
排除标准
- •Participants who meet any below mentioned criterion among CPF-CD, CD-RVF, and CCF diagnosis will be excluded from the study.
- •Current participation in interventional clinical trials.
- •Has CPF-CD: fistula connection to bladder or another organ
- •Has CCF: diagnosis of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis, and Crohn's Disease (CD).
研究组 & 干预措施
Participants With CPF-CD
Participants diagnosed with CPF-CD will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.
Participants With CD-RVF
Participants diagnosed with CD-RVF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.
Participants With CCF
Participants diagnosed with CCF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.
结局指标
主要结局
Percentage of Participants who Achieve Clinical Remission of Fistula
时间窗: Baseline up to 24 months
Clinical remission for Complex perianal fistula in Crohn's Disease (CPF-CD) and Complex Cryptoglandular Fistula (CCF) is defined as closure of all index treated external fistula openings that were draining at baseline as assessed clinically despite gentle finger compression. Clinical remission for Rectovaginal fistula with Crohn's Disease (CD-RVF) is defined as epithelization of the index external fistula opening (vaginal opening) compared to baseline.
次要结局
- Percentage of Participants who Achieve Combined Remission(Baseline, 3, 6, 12 and 24 months post-index surgery)
- Percentage of Participants With Relapse of Fistula in Clinical Remission(Baseline, 3, 6, 12 and 24 months post-index surgery)
- Percentage of Participants who Achieve Cessation of Drainage in Treated Fistula(Baseline, 3, 6, 12 and 24 months post-index surgery)
- Percentage of Participants With Post-surgical Complications(Baseline, 3, 6, 12 and 24 months post-index surgery)
- Percentage of Participants With New Perianal Abscess(Baseline, 3, 6, 12 and 24 months post-index surgery)