Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Reccurance rate
研究概览
简要总结
Surgical treatment witn lateralization of intergluteal cleft is still gold standard for pilonidal sinus disaease. But nowadays minimally invasive treatment methods such as the use of a diode laser (SiLac, Sinus Laser Closure) to obliterate the coccygeal tract are used more often. The aim of the study is to compare a new minimal invasive method (laser treatment) with traditional method ( Bascom II) in terms of recurrence rate, complications and patients satisfaction with results.
详细描述
Pilonidal sinus disease (PSD): is 26 cases per 100,000 population, affects primarily young adults. One of the problems of surgical treatment of PSD is the frequent development of recurrence. There are various methods of surgical treatment, but the recurrence rate still high up to 67%.
Nowadays, minimally invasive methods for PSD (e.g. the use of a diode laser for sinus obliteration- SiLac, Sinus Laser Closure) compete with traditional methods. This "day-surgery" method significantly reduces the risk of postoperative complications, allows a quicker return to normal daily activity, preserves the intergluteal cleft and provides the best cosmetic results. According to some authors, the recurrence rate in this method is up to 26%, parallel others- recurrence rate is less 3 %, but the follow-up does not exceed 2 years.
On the other hand, the excision of the PSD with the mobilization of the skin-subcutaneous flap, which leads to the lateralization of the postoperative scar to one side of the intergluteal cleft hereby providing a low recurrence rate (up to 4%) .
Thus, despite the increased use of minimally invasive surgery, excision of the pilonidal sinus disease cannot be undoubtedly abandoned due to the lack of comparative studies.
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
- Double (Participant, Outcomes Assessor)
盲法说明
double
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
- •Written informed consent
- •Chronic primary or recurrent pilonidal sinus at the remission stage.
- •Presence or absence of secondary orifices.
- •Planned surgical treatment with excision of pilonidal sinus.
- •Location of the orifices should not be less than 1 cm.
- •Location of secondary orifices less 2 cm from the natal cleft.
- •Distance between bilateral symmetrical positions of secondary orifices should not be more than 2 cm.
- •Length of the sinus in the greatest dimension, according to the ultrasound of the soft tissue of the sacrococcygeal region, should not exceed 7 cm.
- •Sinus diameter (width) in the greatest dimension should not exceed 3 cm, according to the ultrasound of the soft tissues of the sacrococcygeal region.
- •Sinus must be located directly under the skin, according to the ultrasound findings.
- •Lack of fixation of the cavity to the coccyx, when evaluating data on pelvic contrast-enhanced magnetic resonance imaging (MRI)
- •____ Non-inclusion criteria
- •1. Acute pilonidal sinus abscess
- •The secondary openings (orifice) position more than 3 cm from the midline.
- •Length of the cavity in the greatest dimension, according to the results of ultrasound examination, exceeds 6 cm
- •Width (diameter) of the sinus in the greatest dimension, according to the results of the ultrasound, more than 3 cm.
- •5. ASA > III.
- •Predictable impossibility of following the protocol
排除标准
- •1. The patients lost for the follow-up
- •The patient's refusal to continue participate in the investigation.
- •Impossibility of the operation performing in the planned scope
结局指标
主要结局
Reccurance rate
时间窗: starting from 6 months after surgery and up to 3 years after surgery]
clinical picture of pilonidal sinus and/or appearance of new openings in the intergluteal cleft and/or chronic unhealing wound and/or residual cavity in the wound area as confirmed by the soft tissue ultrasound)
次要结局
- Operative time(1 day)
- Inhospital stay(30 days])
- Overall quality of life(1- 7 days after surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery)
- Wound hemorrhage rate(Within 30 days from surgery])
- Wound healing speed(3 years after surgery)
- Wound seroma rate(90 days after surgery)
- Patient satisfaction with cosmetic results(6 months, 1 year, 3 years)
- Postoperative pain intensity - late postoperative period(On 10th, 14th, 21st, 30 day after surgery])
- Surgical site infection rate(Frame: 3 month after surgery)
- Bloodloss(1 day)
- Postoperative pain intensity(On 1st, 3rd, 5th and 7th postoperative day])
- Secondary surgery rate(3 years after surgery)
研究者
Darya Shlyk
Russian Society of Colorectal Surgeons
Russian Society of Colorectal Surgeons