Comparison of Silac and Phenol Treatments in Primary Pilonidal Sinus Disease: A Prospective Randomized Controlled Trial With 6-Month Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recurrence Rate
研究概览
简要总结
Pilonidal sinus disease is a common condition affecting young adults and is associated with pain, infection, and reduced quality of life. Various minimally invasive treatment options have been developed to reduce recurrence and improve recovery time. Among these methods, Silac (laser ablation) and phenol application are frequently used techniques.
The aim of this prospective randomized controlled trial is to compare the effectiveness and safety of Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients will be randomly assigned to receive either Silac or phenol treatment. The primary outcome of the study is recurrence rate. Secondary outcomes include postoperative pain, healing time, time to return to work, patient satisfaction, and treatment cost.
Patient recruitment is planned over a 6-month period, and each participant will be followed for 6 months after treatment. The total study duration will be 12 months. The results of this study are expected to provide evidence to guide the selection of minimally invasive treatment options for primary pilonidal sinus disease.
详细描述
Pilonidal sinus disease (PSD) is a chronic inflammatory condition commonly affecting young adults and is associated with significant morbidity, including pain, recurrent infections, and impaired quality of life. Minimally invasive treatment approaches have gained popularity in recent years in order to reduce postoperative pain, shorten recovery time, and lower recurrence rates compared to conventional excisional surgery.
Silac (laser ablation of the sinus tract) and phenol application are two minimally invasive techniques currently used in the management of primary pilonidal sinus disease. Although both methods are widely practiced, high-quality comparative evidence regarding their relative effectiveness remains limited.
This prospective randomized controlled trial aims to compare Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients aged 18-64 years with primary disease, a maximum of three pits, and no more than two prior abscess episodes will be included. Patients with recurrent or secondary disease and significant comorbidities will be excluded.
Participants will be randomly allocated in a 1:1 ratio to receive either Silac or phenol treatment. The primary outcome measure is recurrence rate during follow-up. Secondary outcomes include postoperative pain assessed by Visual Analog Scale (VAS), wound healing time, time to return to work, patient satisfaction, and cost analysis.
Patient recruitment will be conducted over a 6-month period. Each participant will be followed for 6 months after treatment, resulting in a total study duration of 12 months. Statistical analysis will be performed to compare outcomes between groups, with significance set at p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 64 years
- •Diagnosis of primary pilonidal sinus disease
- •Maximum of three sinus openings (pits)
- •History of no more than two previous abscess episodes
- •Ability to provide written informed consent
排除标准
- •Recurrent or previously operated pilonidal sinus disease
- •More than three sinus openings
- •More than two previous abscess episodes
- •Acute abscess requiring emergency drainage at presentation
- •Presence of significant uncontrolled comorbidities
- •Pregnancy
- •Inability to comply with follow-up
研究组 & 干预措施
SiLAc Group
Participants assigned to this arm will receive Silac (laser ablation) treatment for primary pilonidal sinus disease.
干预措施: SiLac (Laser Ablation) (Procedure)
Phenol Group
Participants assigned to this arm will receive phenol application treatment for primary pilonidal sinus disease.
干预措施: Phenol Application (Procedure)
结局指标
主要结局
Recurrence Rate
时间窗: 6 month
Recurrence of pilonidal sinus disease defined as the presence of a new sinus opening, discharge, abscess formation, or need for additional surgical intervention during follow-up.
次要结局
- Treatment Cost(During the 6-month follow-up period)
- Postoperative Pain (VAS Score)(Postoperative day 1 and week 1)
- Postoperative Analgesic Consumption(Within the first postoperative week)
- Wound Healing Time(Up to 6 months)
- Wound-Related Complications(Within 6 months after treatment)
- Time to Return to Work(Within 6 months after treatment)
- Patient Satisfaction(At 6 months after treatment)
研究者
Mehmet Alperen Uğur
M.D, General Surgeon
Izmir City Hospital