Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control (LCPSwUsC)

September 15, 2026 updated by: State Scientific Centre of Coloproctology, Russian Federation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
wound epithelization
Time Frame: 60 days

visual epithelization of all postoperative wounds by 60 days after surgery
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State Scientific Centre of Coloproctology, Russian Federation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow
Research Institute of the Regional Clinical Hospital No. 1 named after Professor S. V. Ochapovsky
Regional State budgetary healthcare institution Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk
Federal State Budgetary Institution National Medical Center for Coloproctology named after A.N. Ryzhikh, Moscow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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