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.
• 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.
• 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.
Parallel
LASER COAGULATION OF THE PILONIDAL SINUS
Procedure/SurgeryStandard 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
Procedure/SurgeryStandard 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.
wound epithelization
visual epithelization of all postoperative wounds by 60 days after surgery
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State Scientific Centre of Coloproctology, Russian Federation
Lead sponsor
State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow
Collaborator
Research Institute of the Regional Clinical Hospital No. 1 named after Professor S. V. Ochapovsky
Collaborator
Regional State budgetary healthcare institution Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk
Collaborator
Federal State Budgetary Institution National Medical Center for Coloproctology named after A.N. Ryzhikh, Moscow
Collaborator
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