Clinical trial · Interventional
Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
Laser Coagulation in the Treatment of Pilonidal Sinus With Intraoperative Ultrasound Control: Multicenter Prospective Randomized Trial.
NCT07829315CI-TRIAL-00126465LCPSwUsCnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Cyst Without Abscess | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LASER COAGULATION OF THE PILONIDAL SINUS | Procedure | — | UNRESOLVED |
| LASER COAGULATION OF THE PILONIDAL SINUS WITH ULTRASONIC CONTROL | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar
- description
- 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.
- interventionNames
- Procedure: LASER COAGULATION OF THE PILONIDAL SINUS
- type
- ACTIVE_COMPARATOR
- label
- LASER COAGULATION OF THE PILONIDAL SINUS Arm Description: performing a standar with ultrasound cont
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.