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Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
Sponsor: State Scientific Centre of Coloproctology, Russian Federation
Summary
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.
Official title: Laser Coagulation in the Treatment of Pilonidal Sinus With Intraoperative Ultrasound Control: Multicenter Prospective Randomized Trial.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2026-09-01
Completion Date
2028-09-01
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
LASER COAGULATION OF THE PILONIDAL SINUS
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 epithelial coccygeal passage and secondary passages. After that, the cyst 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 cyst length.
LASER COAGULATION OF THE PILONIDAL SINUS WITH ULTRASONIC CONTROL
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 epithelial coccygeal passage and secondary passages. After that, the cyst 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 cyst length.