NL-OMON56718招募中不适用
Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA trial (Laser And Pit-picking OR Pit-picking Alone) - LA POPA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 431
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •All patients aged 12 years and older who present with primary pilonidal sinus
- •disease; Type 1b and 3 of the Dutch staging system
- •Obtained written informed consent by the patient and/or legal
- •representative/parent
- •Sufficient understanding of the Dutch written language (reading and writing)
- •Eligible for questionnaires sent by e-mail
排除标准
- •Asymptomatic (Type 1a), recurrent (Type 4; except those patients who only
- •have had drainage of their abscess and no other surgical treatment), or chronic
- •wounds (hypergranulating) after PSD surgery (Type 5) of the Dutch staging
- •Patients with known underlying or concomitant medical conditions that may
- •interfere with normal wound healing (e.g. systemic skin and connective tissue
- •diseases, any kind of congenital defect of metabolism including
- •insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy,
- •chronic hypothyroidism, congenital or acquired immunosuppressive condition,
- •chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or
- •C), severe malnutrition, or other concomitant illness which, in the opinion of
- •the investigator, has the potential to significantly delay wound healing)
- •Severe drug abuse (and therefore protocol deviation can be expected)
- •Patients expected not to comply with the study protocol (including patients
- •with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- •Patients with insufficient knowledge of the Dutch written language who are
- •thus unable to answer the questionnaires
- •Patients that are unable or not willing to give full informed consent
研究者
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