Pilonidal Cyst Without AbscessLCPSwUsCNCT07829315
Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
A study testing LASER COAGULATION OF THE PILONIDAL SINUS in people with Pilonidal Cyst Without Abscess, run by State Scientific Centre of Coloproctology, Russian Federation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pilonidal Cyst Without Abscess
- What is being tested?
- LASER COAGULATION OF THE PILONIDAL SINUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pilonidal Cyst Without Abscess
- Being tested
- LASER COAGULATION OF THE PILONIDAL SINUS, LASER COAGULATION OF THE PILONIDAL SINUS WITH ULTRASONIC CONTROL
- Keywords
- Pilonidal sinus, pilonidal cyst, Laser coagulation, laser 1940 nm
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASER COAGULATION OF THE PILONIDAL SINUSProcedure or surgery
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 CONTROLProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: LASER COAGULATION OF THE PILONIDAL SINUS WITH ULTRASONIC CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound epithelization
visual epithelization of all postoperative wounds by 60 days after surgery
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Cyst Without AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Chronic inflammation of the pilonidal sinus, 2 to 9 cm long, with no signs of active inflammation.
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829315
- Sponsor's protocol ID
- 4444
- Acronym
- LCPSwUsC
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Coagulation in the Treatment of Pilonidal Sinus With Intraoperative Ultrasound Control: Multicenter Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT07829315
- Acronym / sponsor ID
- LCPSwUsC / 4444
- Conditions
- Pilonidal Cyst Without Abscess
- Keywords
- Pilonidal sinus, pilonidal cyst, Laser coagulation, laser 1940 nm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Collaborators
- 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 start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Chronic inflammation of the pilonidal sinus, 2 to 9 cm long, with no signs of active inflammation.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar | Active comparator | Procedure: LASER COAGULATION OF THE PILONIDAL SINUSStandard 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. |
| LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar with ultrasound cont | Active comparator | Procedure: LASER COAGULATION OF THE PILONIDAL SINUS WITH ULTRASONIC CONTROLStandard 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • chronic inflammation of the pilonidal sinus;
Key exclusion criteria (3 listed)
- • acute inflammation (abscess) of the pilonidal sinus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASER COAGULATION OF THE PILONIDAL SINUSStandard 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. | Procedure or surgery | Active Comparator: LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar |
| LASER COAGULATION OF THE PILONIDAL SINUS WITH ULTRASONIC CONTROLStandard 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. | Procedure or surgery | LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar with ultrasound cont |
Primary outcome
wound epithelization
Time frame: 60 days
visual epithelization of all postoperative wounds by 60 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Pilonidal Cyst Without Abscess
Recruiting
The Effect of Local Anesthesia Techniques on Postoperative Pain After Laser Treatment of Pilonidal Sinus
Pilonidal Cyst and Sinus Without Abscess, Pilonidal Sinus Disease
Not yet recruitingObservational study
SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.
Pilonidal Sinus Disorder, Pilonidal Cyst Without Abscess
Not yet recruiting
Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)
Pilonidal Sinus, Pilonidal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LASER COAGULATION OF THE PILONIDAL SINUS in people with Pilonidal Cyst Without Abscess, run by State Scientific Centre of Coloproctology, Russian Federation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound epithelization (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.