Pilonidal Sinus Disease, Sacrococcygeal Pilonidal Sinus Disease
Conditions
Keywords
Pilonidal sinus disease, Laser ablation, Crystallized phenol, Randomized trial, Postoperative pain, Recurrence, Complete epithelialization
Brief summary
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
PROCEDURELaser Ablation
After a small incision, hair and debris removal, and curettage, laser ablation is performed using a Leonardo Mini 1470 nm diode laser.
PROCEDURECrystallized phenol application
After a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity.
Sponsors
Sanliurfa Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomized in a 1:1 ratio to either laser ablation or crystallized phenol treatment in a parallel-group design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative day 1 pain score | Postoperative day 1 | Pain intensity on postoperative day 1 assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete epithelialization at day 30 | Postoperative day 30 | Presence or absence of complete epithelialization of the wound at postoperative day 30. |
| Time to complete epithelialization | Up to 30 days | Time from treatment to complete epithelialization, measured in days. |
| Postoperative day 7 pain score | Postoperative day 7 | Pain intensity on postoperative day 7 assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain. |
| Duration of analgesic use | Up to 30 days | Duration of postoperative analgesic use, measured in days. |
| Time to return to daily activities | Up to 30 days | Time required to return to normal daily activities, measured in days. |
| Time to return to work | Up to 30 days | Time required to return to work, measured in days. |
| Incidence of early local complications | Within 30 days after treatment | Number and proportion of participants who develop any early local postoperative complication. |
| Recurrence at 6 months | 6 months | Presence or absence of recurrent pilonidal sinus disease by 6 months after treatment. |
Contacts
CONTACTVedat Kaplan
Outcome results
None listed