Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control (LCPSwUsC)
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
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
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. |
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. |
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
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
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4444
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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