Research

JAMA Surgery | Original Investigation

Laser Epilation as an Adjunct to Standard Care in Reducing

Pilonidal Disease Recurrence in Adolescents and Young Adults
A Randomized Clinical Trial
Peter C. Minneci, MD, MHSc; Lindsay A. Gil, MD, MPH; Jennifer N. Cooper, PhD; Lindsey Asti, PhD;
Leah Nishimura, BA; Carley M. Lutz, BS; Katherine J. Deans, MD, MHSc

Visual Abstract
IMPORTANCE Recurrence continues to be a significant challenge in the treatment and Supplemental content
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. Author Affiliations: Center for
LE should be considered a standard treatment modality for patients with pilonidal disease Surgical Outcomes Research, Abigail
and should be available as an initial treatment option or adjunct treatment modality for all Wexner Research Institute,
Nationwide Children’s Hospital,
eligible patients. Columbus, Ohio (Minneci, Gil,
Cooper, Asti, Nishimura, Lutz);
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03276065
Department of Pediatric Surgery,
Nationwide Children’s Hospital, The
Ohio State University College of
Medicine, Columbus (Minneci, Gil);
Department of Surgery, Nemours
Children’s Health, Delaware Valley,
Wilmington (Minneci, Deans).
Corresponding Author: Peter C.
Minneci, MD, Department of Surgery,
Nemours Children’s Health Delaware
Valley, 1600 Rockland Rd,
JAMA Surg. doi:10.1001/jamasurg.2023.5526 Wilmington, DE 19806 (peter.
Published online November 8, 2023. [email protected]).

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 Research Original Investigation Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults

P
ilonidal disease is a common condition with reported
incidence rates ranging from 26 to 100 per 100 000 with Key Points
peak incidence occurring near the end of the second de-
Question Is laser epilation (LE) as an adjunct to standard care
cade of life.1-6 It appears to be an acquired disease with evi- more effective in reducing pilonidal disease recurrence than
dence of associations with presence of hair at the gluteal cleft, standard care alone?
sedentary lifestyle, and chronic irritation or trauma to the
Findings In this randomized clinical trial of 302 adolescents and
area1,7,8 and is characterized by intermittent episodes of acute
young adults, recurrence rates over 1 year were significantly lower
inflammatory flares and quiescent disease, sometimes result- in the LE group vs the standard care group. There were no
ing in the development of chronic wounds and fistulas.1,9 The differences in patient or caregiver disability days, patient- or
chronicity of pilonidal disease and high recurrence rates con- caregiver-reported health-related quality of life, health care
tribute to the significant morbidity associated with the dis- satisfaction, or perceived stigma.
ease. Due to the paucity of evidence for an optimal treatment Meaning LE as an adjunct to standard care was effective in
approach and lack of a standardized definition for recur- reducing recurrence of pilonidal disease compared with standard
rence, there is wide practice variation in management strate- care alone.
gies and variability in reported recurrence rates, ranging from
0% to 66%.10-16 Recurrence remains a significant challenge and
imposes considerable physical and psychosocial burden in a
particularly vulnerable age group. ticipants. This study followed the Consolidated Standards of
Conservative preventive strategies to mitigate the risk fac- Reporting Trials (CONSORT) reporting guidelines.
tors associated with pilonidal disease have been gaining ac-
ceptance as an initial treatment approach. Several prior stud- Study Participants and Randomization
ies have demonstrated that initial conservative management Adolescents and young adults 11 to 21 years of age with a his-
with persistent hygiene, nonepilation hair removal, and life- tory of at least 1 episode of pilonidal disease without active dis-
style modification is associated with a reduction in the need ease were enrolled. Exclusion criteria included the following:
for operation.17-19 However, patient compliance with these (1) history of photosensitivity and (2) presence of acute flare
management strategies tends to be low, and laser epilation (LE) with active inflammation or infection. Participants were ran-
therapy has emerged as a potential treatment modality that domly assigned in a 1:1 ratio using a randomized block scheme
may reduce recurrence.14 LE involves removal of the hair shaft, with blocks of size 4 or 6 with lengths chosen randomly with
follicle, and bulb via selective thermolysis. Heating of spe- equal probability using a web-based system. Given the na-
cific target chromophores, such as melanin, results in dam- ture of the interventions, both participants and research team
age to follicular bulge cells with scattered apoptosis and full- members were aware of the assigned intervention. Race and
thickness necrosis of the follicles without dissipation to the ethnicity data were collected to allow for assessment of their
surrounding tissue.20 Several retrospective and prospective associations with recurrence of pilonidal disease. Partici-
studies have demonstrated the efficacy of LE in reducing pi- pants self-identified with the following race and ethnicity cat-
lonidal disease recurrence in both adults and children.21-31 egories: American Indian or Alaska Native, Asian, non-
However, these studies had small sample sizes and were Hispanic Black, Hispanic, Native Hawaiian or Other Pacific
not controlled enough to support a definitive treatment Islander, multiracial, non-Hispanic White, or not reported.
recommendation.26,30,32,33 This trial compared the effective-
ness of LE as an adjunct to standard care with improved hy- Study Groups and Interventions
giene and mechanical or chemical depilation vs standard care Standard Care (Control)
alone in preventing recurrence of pilonidal disease. The control group treatment regimen was based on recom-
mendations from published studies and guidelines and in-
cluded recommendation for improved hygiene and ongoing
mechanical or chemical depilation of hair in the gluteal
Methods cleft. 30,35-37 Control group participants had an initial in-
Study Overview person visit during which they received a standardized level
This was a single-institution, randomized clinical trial com- of education and training about hair removal. Chemical (cream
paring the effectiveness of LE as an adjunct to standard care application as directed) or mechanical depilation (shaving) as
vs standard care alone in reducing recurrence of pilonidal dis- needed to keep the area hair free was recommended. They were
ease in adolescents and young adults. Patients were ran- given supplies to perform hair removal for 6 months with the
domly assigned to either LE plus standard care or standard care recommendation to continue regular hair removal until the pa-
alone. The protocol is registered with ClinicalTrials.gov, and tient reaches 30 years of age.35 The patient and family were
details of the design and methodology have been published.34 also given the option to schedule additional in-person visits
The study protocol and protocol changes are available in for further education and training as desired.
Supplement 1 and eTable 1 in Supplement 2, respectively. The
Nationwide Children’s Hospital institutional review board ap- LE Therapy (Intervention)
proved this study, and written informed consent and assent The intervention group underwent LE therapy in addition to
(for participants <18 years of age) were obtained from all par- the best recommended standard of care. The intervention was

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 Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults Original Investigation Research

based on results from previously reported studies and in- that recurrence rates might be lower due to both groups using
cluded 1 treatment every 4 to 6 weeks for a total of 5 the best available standard of care (as compared with usual
treatments.21-33 Fitzpatrick skin type classification was as- care), more conservative estimates of 1-year recurrence of 12%
sessed, and patients underwent treatment with either a di- in the control group and 2% in the LE group were used. Based
ode 810-nm (for Fitzpatrick skin types I-IV) or Nd:YAG 1064-nm on these estimates, under a group sequential design with 1 in-
(for Fitzpatrick skin types V-VI) laser device.20 Similar to the terim and 1 final analysis, an overall type I error rate (2-sided)
control group, patients and families were taught hair removal of 5% and power of 80%, the sample size required was 123 pa-
techniques at the initial visit and asked to perform either chemi- tients in each group. Assuming a 10% dropout rate over the
cal or mechanical depilation as needed to keep the area hair course of the 1 year, we planned to enroll 136 patients in each
free between laser treatments. group for a total of 272 patients.

Primary and Secondary Outcomes Study Changes Related to the COVID-19 Pandemic
The primary outcome was the rate of recurrence of pilonidal COVID-19 related shutdowns caused the study to halt laser
disease at 1 year. Recurrence was defined as the development treatment appointments. This resulted in a group of
of a new pilonidal abscess, folliculitis, or draining sinus after approximately 15 patients who were randomly assigned and
treatment requiring antibiotic therapy, additional surgical in- enrolled in the LE group who never started treatments and
cision and drainage, or excision. Recurrence data were ob- no longer wanted to participate due to lack of interest or
tained from patient and caregiver questionnaires and local inability or unwillingness to receive treatments due to con-
medical record review. cerns about COVID-19 infection. This unanticipated loss of
Secondary outcomes included patient disability days (de- patients in the LE group necessitated increasing our sample
fined as the total number of days over 1 year in which the pa- size with randomization of an additional 30 patients to
tient was not able to participate in all normal activities sec- maintain power.
ondary to pilonidal disease), caregiver disability days (defined The COVID-19 pandemic also delayed continued laser treat-
as the total number of days over 1 year in which the caregiver ments for several patients in the LE group. These patients com-
was not able to carry out a normal full schedule at work and/or pleted all follow-up surveys as scheduled and completed ad-
home secondary to their child’s pilonidal disease), health- ditional surveys correlating with their treatments for 6
related quality of life (HRQOL; measured using the Pediatric additional months after their last laser treatment.
Quality of Life Inventory [PedsQL] 4.0 Generic Core Scales,
Child and Parent Report with a scale range of 0-100; higher Statistical Analysis
scores indicate better HRQOL),38-42 health care satisfaction All patient baseline sociodemographic and clinical characteris-
(measured using the PedsQL 3.0 Health Care Satisfaction Ge- tics were summarized overall and between groups. For the pri-
neric Module Parent Report with a scale range of 0-100; higher mary outcome of recurrence within 1 year, we calculated the pro-
scores indicate greater satisfaction),38,43 disease-related atti- portion and its 95% CI using the Wilson method and compared
tudes (measured using the Child Attitude Toward Illness Scale this proportion between groups using a Fisher exact test. All out-
[CATIS] with a score range of 1-5; higher scores indicate a more come comparisons were conducted using an intention-to-treat
positive attitude),44,45 disease-related stigma (measured using analysis approach. Categorical secondary outcomes were as-
the Parent and Child Stigma Scales with a score range of 1-5; sessed using estimated proportions and CIs and compared be-
higher scores indicate greater perceived stigma),46 rates of pi- tween groups using Fisher exact tests or Pearson χ2 tests as ap-
lonidal disease-related health care utilization (including emer- propriate. Continuous secondary outcomes were assessed using
gency department/urgent care visits, hospital admissions, and medians and IQRs and compared between groups using
clinic visits), rates of pilonidal disease-related procedures (ie, Mann-Whitney U tests. Longitudinal analyses of secondary out-
incision and drainage or debridement procedures, surgical ex- comes were performed using linear mixed-effects models with
cisions), and postoperative complications (ie, wound infec- random patient-level intercepts that included the baseline value
tion, wound breakdown), and rates of compliance with rec- and all follow-up values of the measure. Overall average pro-
ommended treatment (defined as self-reported confirmation portions of compliance across all time points were calculated
of having performed mechanical or chemical depilation at least using marginal logistic regression models fit using generalized
once in the previous month [standard care group] or under- estimating equations. Trends over time were analyzed using lo-
going 5 laser treatment sessions within 6 months or less gistic mixed-effects regression models with random patient-
[LE group]). level intercept and linear time effects.
Primary and secondary outcomes were assessed through- Patients who were lost to follow-up or withdrew were cen-
out the study period. A summary of the follow-up time points sored from longitudinal analyses after that date. Due to the
and outcome measures assessed at each time point can be COVID-19 pandemic, we performed an as-treated analysis com-
found in eTable 2 in Supplement 2. paring patients in the control group with patients in the laser
group using true length of follow-up and a sensitivity analy-
Sample Size and Power Calculations sis that excluded patients receiving LE who were affected by
Based on the available data, initial estimates for 1-year recur- the COVID-19 delay. Statistical analyses were performed using
rence rates were expected to be 20% in the control group and SAS software, version 9.4 (SAS Institute). All P values were
5% in the LE group. Due to concerns from the funding agency 2-sided, and P < .05 was considered significant.

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 Research Original Investigation Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults

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

545 Patients assessed for eligibility

243 Excluded
67 Did not meet inclusion criteria
51 Declined to participate
125 Unable or unwilling to return
for potential additional visits

302 Randomized Reasons provided for loss to

follow-up were unable to reach
and/or busy patient schedule.
151 Randomized to receive laser epilation 151 Randomized to receive standard care a
A total of 22 patients (20 laser
131 Received laser epilation 149 Received standard care
20 Did not receive laser epilationa 2 Did not receive standard carea epilation, 2 standard care) were lost
to follow-up before any data were
collected and are not included in
115 Lost to follow-up 81 Lost to follow-up analyses or represented in the
14 at 2 mo 11 at 2 mo follow-up results. Of the 20 patients
16 at 3 mo 12 at 3 mo randomly assigned to laser
23 at 6 mo 18 at 6 mo treatment who did not receive laser
25 at 9 mo 18 at 9 mo epilation therapy, 15 withdrew from
37 at 12 mo 22 at 12 mo the study after the COVID-19
shutdown due to concerns about
potential COVID-19 infection risk
96 Included in the primary analysis 134 Included in the primary analysis
associated with multiple visits to the
hospital.

Primary and Secondary Outcomes

Results 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 pro-
Enrollment and Follow-Up portion of patients who experienced a recurrence within 1 year
A total of 545 patients were screened, of which 243 (44.6%) was lower in the LE arm (10 of 96 [10.4%]; 95% CI, 5.8%-
were excluded (Figure). Of the 302 enrolled participants (me- 18.1%) than in the standard care arm (45 or 134 [33.6%]; 95%
dian [IQR] age, 17 [15-18] years; 157 male [56.1%]; 123 female CI, 26.1%-41.9%; mean difference, −23.2%; 95% CI, −33.2% to
[43.9%]), 151 were randomly assigned to each intervention −13.1%; P < .001). There were no significant differences be-
group. However, a total of 280 patients (92.7%) received the tween groups in patient disability days, caregiver disability
allocated treatment with 22 patients (7.3%; 20 LE and 2 con- days, HRQOL scores, health care satisfaction scores, or per-
trol) never completing their initial visit. Therefore, a total of ceived stigma (Table 2). However, patients in the LE group had
280 patients were followed up (131 laser treatment, 149 stan- significantly higher disease-related attitude scores at 6 months
dard care). The Figure details participant flow and follow-up (median [IQR] CATIS, 3.8 [3.4-4.2] vs 3.6 [3.2-4.1]; P = .01). In
rates. Comparisons of patient characteristics between those contrast, they also experienced a greater increase over time in
who did and did not initiate treatment and those with and with- their caregiver-reported disease-related perceived stigma
out primary outcome data are shown in eTables 3 and 4 in (B = 0.03; 95% CI, 0.01-0.06; P = .01) (Table 2). There were also
Supplement 2. no differences in pilonidal disease-related health care utiliza-
tion, procedures, or postoperative complications (Table 3). Both
Demographics and Clinical Characteristics patients in the LE arm who required operative intervention un-
Baseline demographic and clinical characteristics are shown derwent trephination. Of the 8 patients who required opera-
in Table 1. The groups were similar in most measured vari- tive intervention in the standard care arm, 6 patients under-
ables, with absolute standard differences less than 10% with went trephination, and 2 patients underwent cleft lift
the exceptions of race and ethnicity, type of health insur- procedures. In the LE arm, there were no burns and no inabil-
ance, primary caregiver education, total household income, ity to tolerate treatment due to pain. Of the 126 patients in the
whether more than 1 language was spoken at home, the num- LE group who reported pain scores from any of their treat-
ber of prior episodes of pilonidal disease, body mass index, ments, the mean pain score across all treatments per patient
CATIS, and caregiver-reported disease-related stigma score. Pa- was 0.56 (range, 0-4.2), and 60.3% of patients (76 of 126) had
tients self-identified with the following race and ethnicity cat- a mean pain score across all treatments of 0.
egories: 2 American Indian or Alaska Native (0.7%), 8 Asian
(2.9%), 31 non-Hispanic Black (11.1%), 6 Hispanic (2.1%), 2 Na- Assessment of Compliance With Treatment
tive Hawaiian or Other Pacific Islander (0.7%), 15 multiracial In the standard care group, patient-reported compliance with
(5.4%), 210 non-Hispanic White (75.0%), and 6 not reported treatment revealed an average of 79.9% (95% CI, 74.5%-
(2.1%). 84.5%; P = .07) over 1 year with no trend in compliance over

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 Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults Original Investigation Research

Table 1. Patient Demographics and Clinical Characteristics

Characteristic Overall (n = 280) Laser (n = 131) Standard care (n = 149)

Patient demographics
Age, median (IQR), y 17 (15-18) 17 (15-18) 17 (15-18)
Sex, No. (%)
Male 157 (56.1) 71 (54.2) 86 (57.7)
Female 123 (43.9) 60 (45.8) 63 (42.3)
Race and ethnicity, No. (%)
American Indian or Alaska Native 2 (0.7) 1 (0.8) 1 (0.7)
Asian 8 (2.9) 3 (2.3) 5 (3.4)
Non-Hispanic Black 31 (11.1) 8 (6.1) 23 (15.4)
Hispanic 6 (2.1) 3 (2.3) 3 (2.0)
Native Hawaiian or Other Pacific Islander 2 (0.7) 2 (1.5) 0
Multiracial 15 (5.4) 8 (6.1) 7 (4.7)
Non-Hispanic White 210 (75.0) 103 (78.6) 107 (71.8)
Not reported 6 (2.1) 3 (2.3) 3 (2.0)
Insurance, No. (%)
Public 78 (27.9) 32 (24.4) 46 (30.9)
Private 188 (67.1) 95 (72.5) 93 (62.4)
Other 4 (1.4) 1 (0.8) 3 (2.0)
None 10 (3.6) 3 (2.3) 7 (4.7)
Education of primary caregiver, No. (%)
<High school 11 (3.9) 3 (2.3) 8 (5.4)
High school or GED 39 (13.9) 24 (18.3) 15 (10.1)
Some college 45 (16.1) 19 (14.5) 26 (17.5)
Associates 35 (12.5) 17 (13.0) 18 (12.1)
Bachelors 72 (25.7) 28 (21.4) 44 (29.5)
Masters 58 (20.7) 29 (22.1) 29 (19.5)
Doctorate 7 (2.5) 5 (3.8) 2 (1.3)
Professional degree 4 (1.4) 3 (2.3) 1 (0.7)
Not reported 9 (3.2) 3 (2.3) 6 (4.0)
Total household income, No. (%)a
<$25 000 22 (7.9) 9 (6.9) 13 (8.7)
$25 000- $49 999 55 (19.6) 22 (16.8) 33 (22.2)
$50 000 -$99 999 73 (26.1) 36 (27.5) 37 (24.8)
≥$100 000 122 (43.6) 62 (47.3) 60 (40.3)
Not reported 8 (2.9) 2 (1.5) 6 (4.0)
More than 1 language spoken at home, No./total No. (%) 30/270 (10.7) 18/128 (13.7) 12/142 (8.1)
Clinical characteristics
No. of prior episodes of pilonidal disease, No. (%)
1 206 (73.6) 93 (71.0) 113 (75.8)
2 57 (20.4) 28 (21.4) 29 (19.5)
>2 17 (6.1) 10 (7.6) 7 (4.7)
Body mass index,b No. (%)
Underweight or normal weight 93 (33.2) 49 (37.4) 44 (29.5)
Overweight 63 (22.5) 25 (19.1) 38 (25.5)
Obese 112 (40.0) 52 (39.7) 60 (40.3)
Not documented 12 (4.3) 5 (3.8) 7 (4.7)
Any prior surgical excision 47 (16.8) 24 (18.3) 23 (15.4)
Patient-reported PedsQL score, median (IQR) [total No.]c 88.0 (78.3-96.7) [273] 87.0 (79.3-96.2) [128] 89.1 (77.2-96.7) [145]
Caregiver-reported PedsQL score, median (IQR) [total No.]c 89.1 (77.2-97.3) [196] 90.2 (77.2-97.8) [92] 89.1 (75.0-96.7) [104]
CATIS, median (IQR) [total No.]d 3.6 (3.2-3.9) [277] 3.7 (3.2-4.0) [130] 3.5 (3.1-3.8) [147]
Patient-reported disease-related stigma score, 2.0 (1.4-2.4) [279] 2.0 (1.4-2.5) [130] 2.0 (1.4-2.3) [149]
median (IQR) [total No.]e
Caregiver-reported disease-related stigma score, 1.4 (1.0-2.2) [201] 1.4 (1.0-2.2) [94] 1.6 (1.0-2.2) [107]
median (IQR) [total No.]e
c
Abbreviations: CATIS, Child Attitude Toward Illness Score; GED, general The possible range of scores on the PedsQL is 0 to 100, with higher scores
education development; PedsQL, Pediatric Quality of Life. indicating better health-related quality of life.
a d
For 12 patients 18 years or older who reported being financially independent of The possible range of scores on the CATIS is 1 to 5, with higher scores
their parents/guardians, this applies to them and their household (not their indicating a more positive attitude.
parent/guardian or parent/guardian’s household). e
The possible range of scores on the stigma scale is 1 to 5, with higher scores
b
Calculated as weight in kilograms divided by height in meters squared. indicating greater perceived stigma.

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 Research Original Investigation Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults

Table 2. Disability Days, Health-Related Quality of Life, Health Care Satisfaction, Disease-Related Attitude, and Perceived Stigma

Laser Standard care

Median (IQR) Median (IQR) Mean difference
Measure [total No.] Mean (95% CI) [total No.] Mean (95% CI) (95% CI) P valuea P value b
Patient reported
Disability days over 1 y 0 (0-2) [91] 1.4 (0.8 to 0 (0 to 1) [117] 1.9 (0.8 to −0.5 (−1.8 to .07
2.0) 2.9) 0.9)
c
PedsQL score
3 mo 95.7 (85.9 to 90.7 (88.5 to 94.6 (83.7 to 89.9 (87.8 to 0.8 (−2.2 to .69
100) [108] 92.8) 100) [135] 92.0) 3.7)
6 mo 95.7 (85.9 to 90.5 (87.9 to 94.6 (83.7 to 89.7 (87.4 to 0.8 (−2.6 to .37
.12
100) [106] 93.2) 100) [130] 92.0) 4.3)
12 mo 97.8 (89.7 to 92.9 (90.7 to 96.7 (84.8 to 90.3 (87.9 to 2.6 (−0.8 to .30
100) [92] 95.1) 100) [123] 92.7) 6.0)
Health care satisfactiond
1 mo 93.8 (85.9 to 91.6 (88.8 to 89.2 (79.5 to 86.3 (82.1 to 5.3 (0.1 to .11 NA
98.9) [34] 94.3) 97.7) [42] 90.5) 10.5)
CATISe
2 mo 3.7 (3.2 to 3.6 (3.5 to 3.5 (3.2 to 3.5 (3.4 to 0.1 (−0.1 to .33
4.1) [116] 3.7) 4.0) [136] 3.6) 0.2)
6 mo 3.8 (3.4 to 3.8 (3.6 to 3.6 (3.2 to 3.6 (3.5 to 0.2 (0.02 to .01
.33
4.2) [106] 3.9) 4.1) [131] 3.7) 0.3)
12 mo 3.9 (3.4 to 3.7 (3.6 to 3.7 (3.2 to 3.6 (3.5 to 0.1 (−0.03 to .10
4.1) [92] 3.8) 4.1) [126] 3.7) 0.3)
Disease-related stigma scoref
3 mo 1.8 (1.0 to 1.8 (1.7 to 1.9 (1.1 to 1.9 (1.8 to −0.1 (−0.3 to .41
2.3) [113] 2.0) 2.4) [136] 2.0) 0.1)
.11
9 mo 2.0 (1.3 to 2.0 (1.8 to 1.9 (1.4 to 2.0 (1.9 to −0.04 (−0.3 to .81
2.5) [105] 2.1) 2.6) [128] 2.2) 0.2)
Caregiver reported
Disability days over 1 y 0 (0-2) [45] 2.0 (0.7 to 0 (0 to 1) [58] 2.6 (0.7 to −0.6 (−3.1 to .15
3.3) 4.5) 1.8)
PedsQL scorec
3 mo 92.4 (83.7 to 88.9 (85.7 to 95.7 (79.3 to 88.7 (86.0 to 0.2 (−4.0 to .86
100) [71] 92.0) 100) [93] 91.4) 4.3)
6 mo 96.7 (80.4 to 88.6 (85.1 to 94.6 (82.6 to 88.5 (85.2 to 0.1 (−4.6 to .81
.59
100) [65] 92.0) 100) [81] 91.7) 4.8)
12 mo 97.8 (83.2 to 91.2 (87.5 to 95.7 (82.6 to 88.3 (84.1 to 2.9 (−2.8 to .56
100) [44] 95.0) 100) [58] 92.5) 8.7)
Health care satisfactiond
1 mo 96.5 (89.6 to 93.7 (91.8 to 95.7 (85.0 to 90.7 (88.1 to 3.0 (−0.3 to .29 NA
100) [86] 95.5) 100) [96] 93.3) 6.3)
Disease-related stigma scoref
3 mo 1.2 (1.0 to 1.6 (1.4 to 1.4 (1.0 to 1.6 (1.4 to 0.03 (−0.2 to .88
2.0) [76] 1.8) 2.0) [93] 1.7) 0.2)
.01
9 mo 1.8 (1.0 to 1.8 (1.6 to 1.4 (1.0 to 1.7 (1.5 to 0.1 (−0.1 to .23
2.2) [57] 2.0) 2.2) [69] 1.8) 0.4)
Abbreviations: CATIS, Child Attitude Toward Illness Score; NA, not available; indicating better health-related quality of life.
PedsQL, Pediatric Quality of Life. d
Patients were asked about their satisfaction with their health care only if they
a
P values from Mann-Whitney U tests. did not have a participating caregiver in the study.
b e
Overall P value for the interaction between treatment group and time in The possible range of scores on the CATIS is 1 to 5, with higher scores
months (as a continuous variable) from linear mixed effects models with indicating a more positive attitude.
random patient-level intercepts that included the baseline value and all f
The possible range of scores on the stigma scale is 1 to 5, with higher scores
follow-up values of the measure (longitudinal analysis). indicating greater perceived stigma.
c
The possible range of scores on the PedsQL is 0 to 100, with higher scores

time. Caregiver-reported patient compliance with treatment Sensitivity Analyses

demonstrated an average of 80.1% (95% CI, 73.7%-85.3%; Of the 14 patients with laser treatment sessions delayed due
P = .56) over 1 year with no trend in compliance over time. In to the COVID-19 pandemic, only 5 completed a follow-up sur-
the LE group, 60.3% of patients (95% CI, 51.7%-68.3%) were vey 6 months after their last laser session at a median (IQR) of
compliant in undergoing 5 laser treatment sessions in 6 months 453 (430-476) days from baseline. Similar to the primary analy-
or less. When the 14 patients with delayed laser treatments due sis, LE reduced 1-year recurrence in analyses using true fol-
to the COVID-19 pandemic were excluded, compliance was low-up length (mean difference, −21.6%; 95% CI, −32.0% to
67.5% (95% CI, 58.6%-75.3%). −11.2%; P < .001) (eTable 5 in Supplement 2) and when exclud-

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 Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults Original Investigation Research

Table 3. Pilonidal Disease-Related Health Care Utilization, Procedures, and Postoperative Complications Over 1 Year

No. (%) [total No.]

Variable Laser Standard care Difference (95% CI) P value
Disease-related health care utilization
Any emergency department or urgent care visita 7 (7.6) [92] 5 (4.1) [121] −3.5 (−10.0 to 3.0) .28
Any hospital admissiona 0 (0) [92] 5 (4.1) [121] −4.1 (−7.7 to 0.5) .07
Any other visita 21 (22.8) [92] 28 (23.1) [121] −0.3 (−0.12 to 0.11) .96
Disease-related procedures and postoperative complications
Any incision and drainage or debridementb 7 (7.4) [95] 18 (13.9) [130] −6.5 (−14.4 to 1.5) .13
Any surgical excisionb 2 (2.1) [95] 8 (6.3) [128] −4.1 (−9.2 to 1.0) .20
Any wound infectionc 1 (50.0) [2] 2 (25.0) [8] 25.0 (−100.0 to 50.5) >.99
Any wound breakdownc 0 (0) [2] 0 (0) [8] NA NA
b
Abbreviation: NA, not applicable. Patients who had either patient-reported or caregiver-reported pilonidal
a
Patients with either patient-reported or caregiver-reported 12-month disability symptoms data at 12 months or who had this procedure documented in their
day data were included. Health care utilization documented in the patient’s local medical record were included; P values are from χ2 tests.
c
local medical record or that was self- or parent-reported to have occurred not Only patients who had a surgical excision recorded in their local medical record
at Nationwide Children’s Hospital was included. P values are from χ2 tests; this were included.
measure does not include visits for laser treatment.

ing patients in the LE group with delays due to the COVID-19 Rates of pilonidal disease-related health care utilization
pandemic (mean difference, −23.0%; −33.3% to −12.7%; and need for excision were low in both groups with no signifi-
P < .001) (eTable 6 in Supplement 2). cant differences in rates of emergency department visits, hos-
pital admissions, incision and drainage, or surgical excision.
These results are consistent with prior studies that have dem-
onstrated a reduction in the need for operative intervention
Discussion with standard care, as well as LE. One retrospective review18
In this randomized clinical trial, LE as an adjunct to standard demonstrated that after implementation of a 15-day protocol
care significantly decreased pilonidal disease recurrence at 1 that included mechanical depilation, daily sitz baths, and an-
year compared with standard care alone. There were no sig- tibiotics, only 14.7% of patients required surgery. Another
nificant differences in pilonidal disease-related health care uti- study28 evaluated patients who underwent LE therapy at
lization, need for additional procedures, rates of postopera- 1-month intervals for a median of 5.1 months and found that
tive complications, disability days, quality of life, health care only 7% required operative intervention.
satisfaction, or perceived stigma between groups. Patients who There were no differences in disability days, quality-of-
underwent LE had significantly higher attitudes toward their life scores, or health care satisfaction between groups.
pilonidal disease at 6 months, but there was a greater in- Patient- and caregiver-reported median disability days were
crease in caregiver-reported disease-related perceived stigma 0 days in both groups over 1 year. This is likely reflective of both
over time. treatments being minimally invasive with minimal disrup-
Although LE has been demonstrated to be a safe treat- tion to patients’ lives. This is in contrast to more invasive treat-
ment modality for pilonidal disease, there is a lack of rigorous ment modalities such as trephination, which has reported a
prospective studies and significant heterogeneity in the out- time to return to activities of 2 to 16 days, and excisional pro-
comes and patient clinical characteristics in the available cedures, which have reported a time to return to activities of
studies.25,47 In this study, recurrence rates in the standard care anywhere from 1 to 8 weeks.49
and LE groups were similar to previously reported recurrence Pilonidal disease can impart significant psychosocial bur-
rates for each group. One prior study19 investigating recur- den in a particularly vulnerable age group. In a qualitative study
rence after implementation of a conservative management pro- assessing the effect of pilonidal disease on activities of daily
tocol involving mechanical depilation via shaving every 4 to living, 3 emerging themes included difficulty adapting to life
5 days and daily cleaning with chlorine solution demon- despite pilonidal wounds, perceived embarrassment and lack
strated a recurrence rate of 29.1%. With regard to the LE group, of understanding, and loss of control.50 Patients who under-
our study demonstrated a 1-year recurrence rate of 10.4%, cor- went LE had significantly higher CATIS at 6 months com-
roborating the results of a recent systematic review14 of LE for pared with patients who underwent standard care alone. It is
pilonidal disease that reports recurrence rates ranging from 0% possible that during repeated visits for laser treatments, con-
to 28% with mean follow-up duration ranging from 6 months sistent words of encouragement and observing less hair growth
to 5 years. Overall, there have been few comparative studies gave patients hope that the treatment would eventually al-
that have investigated recurrence rates after LE vs other treat- low them to be free of disease. Conversely, although patients
ment modalities.48 This study was the first, to our knowl- undergoing standard care were empowered to take control of
edge, to compare LE as an adjunct to standard care vs stan- their disease, it is possible that they felt more isolated and less
dard care alone and demonstrate a decrease in recurrence rates. optimistic due to the lack of regular scheduled visits. On the

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 Research Original Investigation Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults

other hand, the laser group also experienced a greater any patients. On contacting patients to schedule their laser
increase in caregiver-reported disease-related perceived stigma treatments with clinic reopening, 15 patients who were origi-
over time. This may be due to an increase in parent involve- nally randomly assigned to the LE arm and had not under-
ment in their child’s care due to frequent visits for laser gone their first laser treatment asked to withdraw from the trial
treatments. due to concerns related to the COVID-19 pandemic and the risks
associated with the requirement of multiple visits to the hos-
Limitations pital to receive laser treatments. The potential impact and
This study has several limitations. First, there was the poten- changes to the sample size and analysis plan due to the
tial for participation bias due to the randomized clinical trial COVID-19 pandemic were reviewed and approved by our study
design. However, the overall enrollment of eligible patients was statistician, stakeholders, the data safety monitoring commit-
relatively high at 64% (302 of 478). Second, due to loss to fol- tee, and the funding agency. The 2 sensitivity analyses per-
low-up, there were missing data for primary and secondary out- formed due to changes related to the COVID-19 pandemic dem-
comes, and this was greater in the LE arm. Loss to follow-up onstrated similar results to those in the primary analysis.
in the LE arm accelerated after 6 months, which coincided with Finally, the study was performed at a single tertiary institu-
completion of laser treatments with many patients in the LE tion with recruitment from a single large metropolitan area.
arm who completed laser treatments opting not to complete
the 9- and 12-month surveys, which is not uncommon among
adolescents. Moreover, patients in the standard care group were
more likely to complete follow-up because they were offered
Conclusions
laser therapy on completion of 1-year follow-up at no charge. This randomized clinical trial demonstrates that LE as an ad-
Loss to follow-up was accounted for in our analysis via addi- junct to standard care was significantly more effective in re-
tional sensitivity analyses and censoring from longitudinal ducing pilonidal disease recurrence compared with standard
analyses. Third, there was potential for the COVID-19 pan- care alone. LE should be considered a standard treatment mo-
demic to affect the results of the trial. The COVID-19 pan- dality for patients with pilonidal disease and should be avail-
demic caused a 3-month shutdown in our pilonidal clinic dur- able as an initial treatment option or adjunct treatment mo-
ing which we were unable to administer laser treatments for dality for all eligible patients.

ARTICLE INFORMATION approval of the manuscript; and decision to submit incidence increase in inpatients in 13 years with
Accepted for Publication: August 7, 2023. the manuscript for publication. substantial regional variation in Germany. Int J
Data Sharing Statement: See Supplement 3. Colorectal Dis. 2021;36(10):2135-2145. doi:10.1007/
Published Online: November 8, 2023. s00384-021-03944-4
doi:10.1001/jamasurg.2023.5526 Additional Contributions: We thank our pediatric
surgery clinic staff for their dedication and hard 5. Luedi MM, Schober P, Stauffer VK, Diekmann M,
Author Contributions: Dr Minneci had full access Doll D. Global gender differences in pilonidal sinus
to all of the data in the study and takes work to taking care of patients and making this
study possible; Aesthetic Solutions Inc for providing disease: a random-effects meta-analysis. World J Surg.
responsibility for the integrity of the data and the 2020;44(11):3702-3709. doi:10.1007/s00268-020-
accuracy of the data analysis. the laser equipment necessary to run this study;
and the following stakeholders whose insight and 05702-z
Concept and design: Minneci, Cooper,
Nishimura, Deans. support made this study a success: Nickolas Golden 6. da Silva JH. Pilonidal cyst: cause and treatment.
Acquisition, analysis, or interpretation of data: (patient), Sandy Laube, BA (The Pilonidal Care Dis Colon Rectum. 2000;43(8):1146-1156. doi:10.
Minneci, Gil, Cooper, Asti, Lutz, Deans. Alliance, patient/caregiver advocacy organization), 1007/BF02236564
Drafting of the manuscript: Minneci, Gil, Lutz. Mark Laux (family/caregiver), Jenna King (family/ 7. Franckowiak JJ, Jackman RJ. The etiology of
Critical review of the manuscript for important caregiver), Rebecca King (patient/consumer), Lisa pilonidal sinus. Dis Colon Rectum. 1962;5:28-36.
intellectual content: Minneci, Gil, Cooper, Asti, Rorris (family/caregiver), Jacob Rorris (patient), doi:10.1007/BF02616408
Nishimura, Deans. Delores Perry, RN (nurse), Lauren Parrish, RN
(nurse), Sean Gleason, MD (primary care 8. Harlak A, Mentes O, Kilic S, Coskun K, Duman K,
Statistical analysis: Cooper. Yilmaz F. Sacrococcygeal pilonidal disease: analysis
Obtained funding: Minneci, Deans. practitioner), and Tim Rorris (family/caregiver).
of previously proposed risk factors. Clinics (Sao
Administrative, technical, or material support: Gil, Paulo). 2010;65(2):125-131. doi:10.1590/S1807-
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