Laser Coagulation in the Treatment of Pilonidal Sinus With Intraoperative Ultrasound Control: Multicenter Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 310
- 主要终点
- wound epithelization
研究概览
简要总结
LASER COAGULATION OF THE PILONIDAL SINUS WITH INTRAOPERATIVE US CONTROL: PROTOCOL FOR A PROSPECTIVE MULTICENTER RANDOMIZED CLINICAL STUDY.
Adaptive randomized controlled equivalence study with one planned non-blinded interim analysis.
详细描述
When analyzing the literature data, we did not find any publications that assess the quality of this operation. The technical characteristics of laser radiation, such as power, mode, amount of energy transferred, and type of fiber, are considered in all publications, which is an objective criterion. On the other hand, the surgeon's mechanical treatment and laser exposure of the internal lining of the pilonidal cyst do not have clear criteria for analysis. An intraoperative ultrasound examination can visualize the position of the surgical instrument in the sinus cavity, providing an objective confirmation of the completeness of the surgical intervention. We have proposed criteria for the quality of mechanical and laser treatment of the pilonidal sinus duct based on intraoperative ultrasound examination: the location of the instrument in the lumen of the cyst cavity; the instrument is passed along the entire length of the pilonidal sinus duct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• chronic inflammation of the pilonidal sinus;
- •sinus size according to ultrasound examination is at least 2.0 cm and no more than 9.0 cm.
- •patients over 18 years of age;
- •signed voluntary informed consent to participate in the study.
排除标准
- •• acute inflammation (abscess) of the pilonidal sinus;
- •patients who have previously undergone surgery for chronic inflammation of the pilonidal sinus;
- •presence of severe somatic diseases in the stage of decompensation.
研究组 & 干预措施
Active Comparator: LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar
Standard management protocol: the operation is performed under local infiltration anesthesia, with access from 1-2 points using a 4-6 mm skin trepan. Next, a button probe and a sharp Volkmann spoon are used for probing. Finally, the working part of the light guide is inserted, and ultrasound monitoring is performed to ensure proper orientation of the light guide throughout the pilonidal sinus passage and secondary passages. After that, the sinus is treated with a laser having the following characteristics: wavelength 1940 nm; end-fire; power 9 W; in constant mode. Repeated mechanical and laser treatment is performed with the same laser radiation characteristics, without ultrasonic control. The calculation of the total energy (both effects) does not exceed 200 J per cm of the sinus length.
干预措施: LASER COAGULATION OF THE PILONIDAL SINUS (Procedure)
LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar with ultrasound cont
Standard management protocol: the operation is performed under local infiltration anesthesia, with access from 1-2 points using a 4-6 mm skin trepan. Next, a button probe and a sharp Volkmann spoon are used for probing, followed by intraoperative ultrasound monitoring to confirm the placement of the sharp Volkmann spoon into the cyst lumen and the absence of false passages. Finally, the working part of the light guide is inserted, and ultrasound monitoring is performed to ensure proper orientation of the light guide throughout the pilonidal sinus passage and secondary passages. After that, the sinus is treated with a laser having the following characteristics: wavelength 1940 nm; end-fire; power 9 W; in constant mode. Repeated mechanical and laser treatment is performed with the same laser radiation characteristics, with ultrasonic control. The calculation of the total energy (both effects) does not exceed 200 J per cm of the sinus length.
干预措施: LASER COAGULATION OF THE PILONIDAL SINUS WITH ULTRASONIC CONTROL (Procedure)
结局指标
主要结局
wound epithelization
时间窗: 60 days
visual epithelization of all postoperative wounds by 60 days after surgery
次要结局
未报告次要终点