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NCT Number: NCT07829315

Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control

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.

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Key information

Conditions

Pilonidal Cyst Without Abscess Cysts Neoplasms Pilonidal Sinus

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Treatment and study plan

LASER COAGULATION OF THE PILONIDAL SINUS

Procedure

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

Procedure

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.

Primary outcomes

wound epithelization

Time frame: 60 days

visual epithelization of all postoperative wounds by 60 days after surgery

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Sponsors and collaborators

Lead sponsor

State Scientific Centre of Coloproctology, Russian Federation

Other Gov

Collaborators

Federal State Budgetary Institution National Medical Center for Coloproctology named after A.N. Ryzhikh, Moscow
Regional State budgetary healthcare institution Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk
Research Institute of the Regional Clinical Hospital No. 1 named after Professor S. V. Ochapovsky
State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow

Registry information

Official study title

Laser Coagulation in the Treatment of Pilonidal Sinus With Intraoperative Ultrasound Control: Multicenter Prospective Randomized Trial.

Acronym: LCPSwUsC

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Sep 21, 2026
Registry last updated: Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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