LASER VERSUS CRYSTALLIZED PHENOL IN PILONIDAL SINUS DISEASE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laser Ablation, Crystallized phenol application.
- Who it may be relevant to
- Registry conditions: Sacrococcygeal Pilonidal Sinus Disease, Pilonidal Sinus Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A PROSPECTIVE RANDOMIZED COMPARISON OF LASER ABLATION AND CRYSTALLIZED PHENOL APPLICATION IN PRIMARY UNCOMPLICATED SACROCOCCYGEAL PILONIDAL SINUS DISEASE
Overview
This single-center prospective randomized parallel-group trial compares laser ablation and crystallized phenol application in adults with primary uncomplicated sacrococcygeal pilonidal sinus disease. The primary objective is to compare postoperative day 1 pain intensity between the two treatment methods. Secondary objectives include complete epithelialization by day 30, time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and 6-month recurrence.
Detailed description
This is a single-center, prospective, 1:1 parallel-group randomized clinical trial in adults with primary uncomplicated chronic sacrococcygeal pilonidal sinus disease. A total of 120 participants are planned, with 60 assigned to laser ablation and 60 assigned to crystallized phenol treatment. Randomization will be performed using computer-generated variable blocks, with stratification by pit number and Guner stage when feasible. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. In both groups, a small incision of approximately 1 cm will be made, hair and debris within the sinus cavity will be removed, and curettage will be performed. After these shared preparation steps, the intervention group will receive Leonardo Mini 1470 nm diode laser treatment and the comparison group will receive crystallized phenol application. Repeat sessions with the same assigned treatment may be performed when needed within the secondary healing protocol. The primary endpoint is postoperative day 1 pain intensity measured by Visual Analog Scale. The main secondary endpoint is complete epithelialization at day 30. Other secondary outcomes include time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and recurrence at 6 months.
Interventions
- Procedure Laser Ablation
After a small incision, hair and debris removal, and curettage, laser ablation is performed using a Leonardo Mini 1470 nm diode laser. - Procedure Crystallized phenol application
After a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity.
Primary outcome measures
- Postoperative day 1 pain score [Time frame: Postoperative day 1]
Secondary outcome measures (8)
- Complete epithelialization at day 30 [Time frame: Postoperative day 30]
- Time to complete epithelialization [Time frame: Up to 30 days]
- Postoperative day 7 pain score [Time frame: Postoperative day 7]
- Duration of analgesic use [Time frame: Up to 30 days]
- Time to return to daily activities [Time frame: Up to 30 days]
- Time to return to work [Time frame: Up to 30 days]
- Incidence of early local complications [Time frame: Within 30 days after treatment]
- Recurrence at 6 months [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- Diagnosis of primary chronic sacrococcygeal pilonidal sinus disease
- Uncomplicated disease
- Suitability for minimally invasive treatment
- Provision of written informed consent
Exclusion criteria
- Acute pilonidal abscess
- History of pilonidal abscess drainage
- Previous surgical or interventional treatment for pilonidal sinus disease
- Recurrent pilonidal disease
- Complex pilonidal disease or marked lateral extension
- Immunosuppression, chronic steroid use, or systemic conditions that may significantly impair wound healing
- Inability to attend regular follow-up
- Refusal to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07701772 · SEAH-PİSİ