2022-502659-73-01招募中2 期
Repairing Peri-Anal Fistulas with regenerative cell therapeutics (REP-PAF)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The healing rate (percentage) after observation time of six and twelve months. Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
研究概览
简要总结
This clinical study aims to evaluate the outcome of the treatment of complex crypto-glandular perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>= 18years) with complex PAF (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment
- •and who are able to communicate with Danish language
- •and who are able to communicate with Danish language
- •and who are having address in the region of southern Denmark during the study
排除标准
- •Signs of suppuration/cavitation around the fistula
- •Allergy against the antibiotics: Penicillin and streptomycin.
- •Coagulopathy
- •Pregnancy and lactation (positive HCG test)
- •Verified syphilis, HIV, or hepatitis on screening test
- •Simple or low anal fistula, which can be treated by simple surgical incision
- •Ano-vaginal and recto-vaginal fistula
- •The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
- •Inflammatory Bowel Disease
- •Immunosuppression (due to clinical condition or medical therapy)
- •Malignancy within 5 years
- •Previous radiotherapy of the abdomen and pelvis
- •BMI under 18.5
结局指标
主要结局
The healing rate (percentage) after observation time of six and twelve months. Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
The healing rate (percentage) after observation time of six and twelve months. Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
次要结局
- Functional outcome regarding quality of life and anal continence, measured by Short Form SF-36 Rand questionnaire and Wexner Fecal Incontinence score respectively
- The risk factors for recurrence of PAF
- The radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.
- A comparison of autologous vs. allogenic Adipose-Derived Regenerative Cells (ADRCs) regarding cell characterization, immune responses, and efficacy.
研究者
Research Unit, Department of Surgery
Scientific
Odense University Hospital
研究点 (1)
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