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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser ablation | Experimental | Participants undergo shared sinus preparation followed by laser ablation using a Leonardo Mini 1470 nm diode laser. |
|
| Crystallized phenol | Active Comparator | Participants undergo shared sinus preparation followed by crystallized phenol application to the sinus cavity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Ablation | Procedure | After a small incision, hair and debris removal, and curettage, laser ablation is performed using a Leonardo Mini 1470 nm diode laser. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative day 1 pain score | 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. | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete epithelialization at day 30 | Presence or absence of complete epithelialization of the wound at postoperative day 30. | Postoperative day 30 |
| Time to complete epithelialization | Time from treatment to complete epithelialization, measured in days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vedat Kaplan | Contact | +905459045165 | vedat_kaplan_@hotmail.com |
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Individual participant data will not be shared because this is a single-center clinical study involving sensitive patient-level data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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Participants are randomized in a 1:1 ratio to either laser ablation or crystallized phenol treatment in a parallel-group design.
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| Crystallized phenol application | Procedure | After a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity. |
|
| Up to 30 days |
| Postoperative day 7 pain score | 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. | Postoperative day 7 |
| Duration of analgesic use | Duration of postoperative analgesic use, measured in days. | Up to 30 days |
| Time to return to daily activities | Time required to return to normal daily activities, measured in days. | Up to 30 days |
| Time to return to work | Time required to return to work, measured in days. | Up to 30 days |
| Incidence of early local complications | Number and proportion of participants who develop any early local postoperative complication. | Within 30 days after treatment |
| Recurrence at 6 months | Presence or absence of recurrent pilonidal sinus disease by 6 months after treatment. | 6 months |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |