Affiliation:
1. Center for Surgical Outcomes Research, Abigail Wexner Research Institute, Nationwide Children’s Hospital, Columbus, Ohio
2. Department of Pediatric Surgery, Nationwide Children’s Hospital, The Ohio State University College of Medicine, Columbus
3. Department of Surgery, Nemours Children’s Health, Delaware Valley, Wilmington
Abstract
ImportanceRecurrence continues to be a significant challenge in the treatment and management of pilonidal disease.ObjectiveTo 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 ParticipantsThis 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.InterventionLE and standard care (improved hygiene and mechanical or chemical depilation) or standard care alone.Main Outcomes and MeasuresThe 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.ResultsA 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 RelevanceLE 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 RegistrationClinicalTrials.gov Identifier: NCT03276065
Publisher
American Medical Association (AMA)
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