Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 482
- 主要终点
- Succes rate of treatment
研究概览
简要总结
The goal of this randomized clinical trial is to establish the efficacy of 'pit picking with laser therapy' versus 'pit picking alone' on both short and long-term outcomes in patients of 12 years and older with primary pilonidal sinus disease.
The main questions it aims to answer are:
- The overall success rate of treatment which is defined as: closure of all pits at 12 months of follow-up.
- Secondary endpoints: succes rat eof treatment during long-term follow-up, wound closure time, pain scores, complication rate, work rehabilitation, time to return to daily activities, quality of life, persisting complaints, patient satisfaction, costs and the need for secondary or revision surgery.
Participants will allocated to pit picking alone or combined with lasertherapy.
The extra burden for participating patients is expected to be minimal to moderate. Participants will have two extra hospital visits in casethey are enrolled in our study: 6 and 12 months after enrolment. Postoperatively the normal scheme of follow up appointments wil be used: 2 and 6 weeks after treatment at the outpatient clinic of the treating surgeon. A telephone appointment with the researcher will be scheduled 4 weeks after treatment. Patients are asked to complete questionnaires at various time points, which will be sentto them by email and will take approximately 5-10 minutes each time. The content includes general and disease specific Quality of Life (QoL) questionnaires. The investigators do not expect any extra adverse reactions or events in respect to participation in the study because both procedures are considered standard of care in the participating clinics. However, because both interventions are surgical procedures a small percentage of adverse events or postoperative complications can be expected.
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
- Single (Outcomes Assessor)
盲法说明
Only the outcome assessor is blinded.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 system
- •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
结局指标
主要结局
Succes rate of treatment
时间窗: 1 year
Success rate of treatment, defined as closure of all pits at 1 year follow-up. Closure of the pits will be assessed by the treating surgeon by means of an extensive physical examination.
次要结局
- Success rate of treatment at long-term follow-up(3-5 years)
- Pain score(6 weeks)
- Work rehabilation(6 weeks)
- Recurrence rate(5 years)
- Need for secondary or revision surgery(5 years)
- Return to daily activities(6 weeks)
- Patient reported outcome measures(5 years)
- Wound healing and complications(1 year)
- Patient satisfaction(5 years)
- Quality adjusted life years (QALYs)(5 years)
- Absence of symptoms(1 year)
研究者
dr. IJM Han-Geurts
Local investigator
Proctos Kliniek