"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of adverse events at 6 months
研究概览
简要总结
Background: Complex perianal fistulas pose a challenge to surgeons since the fistulous tract must be eliminated without impairing continence. Biological sealants have emerged as an effective alternative for maintaining the integrity of the anal sphincter. The investigators aimed to assess the feasibility and safety of calcium alginate hydrogel injections into the tract as treatment for complex cryptoglandular fistulas.
Methods: A prospective, single-center, case series of this novel technique was conducted in a level 3 hospital, including patients diagnosed with trans-sphincteric perianal fistulas and treated with a calcium alginate hydrogel sealant. A strict follow-up was performed by an independent surgeon at 1, 3, 6, and 12 months. The main outcome measures were feasibility, safety (number of adverse events) and efficacy of the treatment.
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
- •Signed Informed Consent Form
- •Age ≥18 years
- •Cryptoglandular PAF treated by Seton placement for at least 3 months, with a single External Fistulous Orifice and Internal Fistulous Orifice
排除标准
- •Informed Consent Form not signed or withdrawn
- •Not possible to adhere to follow-up routine
- •Another investigational drug in the previous 3 months
- •Allergy to alginate
- •Grade IV in American Society of Anesthesiologists scale
- •Pregnancy
- •History of radiotherapy in the perineal area
- •Diagnosis or suspicion of Intestinal Blow Disease
- •Immunosuppression, active neoplasia at the time of recruitment or in previous year, or positive for human immunodeficiency virus Internal Fistulous Orifice not located during the procedure
- •Simple anal fistula (submucosa or low Intersphincteric Perianal Fistula, except association with Faecal Incontinence
- •Anal stenosis that prevents exploration
- •Undrained collections >2 cm
- •Rectovaginal fistulas
- •Fistulas of non-cryptoglandular origin
结局指标
主要结局
Incidence of adverse events at 6 months
时间窗: At 6 months
Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Incidence of adverse events at 12 months
时间窗: At 12 months
Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Incidence of adverse events at 1 month
时间窗: At 1 month
Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Incidence of adverse events at 3 months
时间窗: At 3 months
Incidence of adverse events, their relationship to the product under investigation, and their intensity (mild, moderate, or severe)
Incidence of patients treated following the protocol during the surgery
时间窗: During the surgery
Feasibility is measured as the ratio between the number of patients who received the injection following all the steps of the protocol and the total number of individuals included in the study.
次要结局
- Ecographic curation at 12 months(At 12 months)
- Clinical curation at 6 months(At 6 months)
- Clinical curation at 1 month(At 1 month)
- Clinical curation at 3 months(At 3 months)
- Clinical curation at 12 months(At 12 months)