Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control

NCT07829315 | Not Yet Recruiting DMC

• 1 other identifier: 4444
• Study Type: interventional
• Target: 310
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pilonidal Cyst Without Abscess

Keywords

Pilonidal sinus; pilonidal cyst; Laser coagulation; laser 1940 nm

Outcome Measures

Primary Outcomes (1)

• wound epithelization

  visual epithelization of all postoperative wounds by 60 days after surgery

  60 days

Study Arms (2)

Active Comparator: LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar

ACTIVE COMPARATOR

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.

Procedure: LASER COAGULATION OF THE PILONIDAL SINUS

LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar with ultrasound cont

ACTIVE COMPARATOR

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.

Procedure: LASER COAGULATION OF THE PILONIDAL SINUS WITH ULTRASONIC CONTROL

Interventions

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.

Active Comparator: LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar

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.

LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar with ultrasound cont

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead
• 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

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Chronic inflammation of the pilonidal sinus, 2 to 9 cm long, with no signs of active inflammation.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: September 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share