Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults: A Randomized Clinical Trial

Abstract

Importance: Recurrence continues to be a significant challenge in the treatment and management of pilonidal disease.

Objective: To compare the effectiveness of laser epilation (LE) as an adjunct to standard care vs standard care alone in preventing recurrence of pilonidal disease in adolescents and young adults.

Design, setting, and participants: This was a single-institution, randomized clinical trial with 1-year follow-up conducted from September 2017 to September 2022. Patients aged 11 to 21 years with pilonidal disease were recruited from a single tertiary children's hospital.

Intervention: LE and standard care (improved hygiene and mechanical or chemical depilation) or standard care alone.

Main outcomes and measures: The primary outcome was the rate of recurrence of pilonidal disease at 1 year. Secondary outcomes assessed during the 1-year follow-up included disability days, health-related quality of life (HRQOL), health care satisfaction, disease-related attitudes and perceived stigma, and rates of procedures, surgical excisions, and postoperative complications.

Results: A total of 302 participants (median [IQR] age, 17 [15-18] years; 157 male [56.1%]) with pilonidal disease were enrolled; 151 participants were randomly assigned to each intervention group. One-year follow-up was available for 96 patients (63.6%) in the LE group and 134 (88.7%) in the standard care group. The proportion of patients who experienced a recurrence within 1 year was significantly lower in the LE treatment arm than in the standard care arm (-23.2%; 95% CI, -33.2 to -13.1; P < .001). Over 1 year, there were no differences between groups in either patient or caregiver disability days, or patient- or caregiver-reported HRQOL, health care satisfaction, or perceived stigma at any time point. The LE group had significantly higher Child Attitude Toward Illness Scores (CATIS) at 6 months (median [IQR], 3.8 [3.4-4.2] vs 3.6 [3.2-4.1]; P = .01). There were no differences between groups in disease-related health care utilization, disease-related procedures, or postoperative complications.

Conclusions and relevance: LE as an adjunct to standard care significantly reduced 1-year recurrence rates of pilonidal disease compared with standard care alone. These results provide further evidence that LE is safe and well tolerated in patients with pilonidal disease. LE should be considered a standard treatment modality for patients with pilonidal disease and should be available as an initial treatment option or adjunct treatment modality for all eligible patients.

Trial registration: ClinicalTrials.gov Identifier: NCT03276065.

Figure.. Study Flow of Laser Epilation and Standard Care for Pilonidal Disease

Reasons provided for loss to follow-up were unable to reach and/or busy patient schedule. ^aA total of 22 patients (20 laser epilation, 2 standard care) were lost to follow-up before any data were collected and are not included in analyses or represented in the follow-up results. Of the 20 patients randomly assigned to laser treatment who did not receive laser epilation therapy, 15 withdrew from the study after the COVID-19 shutdown due to concerns about potential COVID-19 infection risk associated with multiple visits to the hospital.