Surgery vs Hair Removal for Pilonidal Disease

Overseen By Bill Chiu, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Inability to read, Intellectual disability

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether individuals with pilonidal disease (a skin condition where painful cysts form near the tailbone) require surgery after their symptoms improve with regular hair removal treatments like laser epilation. Participants will either continue with just the hair removal regimen or combine it with surgical excision to assess which approach better prevents symptom recurrence. Individuals with pilonidal disease who receive care at Stanford Healthcare and can read or write English or Spanish may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future treatment options.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that laser hair removal is a safe and well-tolerated method for people with pilonidal disease when used regularly. Studies indicate it can lower the chances of the disease returning. For instance, only 10.4% of patients who combined laser hair removal with standard treatment experienced recurrence after one year. Additionally, a small study found that almost all patients reported improved symptoms and quality of life, with 40% resolving their condition without surgery.

In contrast, surgery, which involves removing the affected area, shows mixed results regarding safety and effectiveness. The chances of recurrence after surgery can vary. One study found a 7.2% recurrence rate, while another reported rates as high as 39.1% over an 18-month period. Long-term results can be even higher, with some cases showing a 67.9% recurrence after 20 years.

Both treatments have distinct safety records and effectiveness. Laser hair removal appears to be a less invasive option with promising results, while surgery carries a risk of recurrence in some cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different approaches to managing pilonidal disease. While traditional treatments often involve surgical excision alone, this trial investigates the impact of combining a regular hair removal routine (epilation) with surgery versus using hair removal alone. This approach could potentially reduce recurrence rates and improve healing times by minimizing hair regrowth, which is a common cause of recurrence. The unique focus on hair management as a preventive measure offers a fresh strategy that could enhance patient outcomes and reduce the need for repeated surgeries.

What evidence suggests that this trial's treatments could be effective for pilonidal disease?

In this trial, participants will join different treatment arms to evaluate the effectiveness of hair removal and surgical options for pilonidal disease. Previous studies have shown that laser hair removal, part of the regular epilation regimen arm, holds promise in reducing the recurrence of pilonidal disease, a painful skin condition near the tailbone. Patients who used laser hair removal experienced fewer recurrences in the first year compared to those who did not. Surgical removal, another treatment option in this trial, has shown mixed success in past studies. Some studies report low recurrence rates after surgery, while others show higher rates over time. The effectiveness of laser hair removal may vary based on individual factors like race and type of insurance. Both treatments offer benefits, but laser hair removal is gaining attention for potentially reducing recurrence rates. ^{1 2 3 4 6}

Who Is on the Research Team?

Bill Chiu, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for patients at Stanford Healthcare over the age of 8 with pilonidal disease, who can read and understand English or Spanish. It's not suitable for those with intellectual disabilities that prevent them from understanding or responding to questionnaires.

Inclusion Criteria

I am older than 8 years.

I am being treated at Stanford Healthcare for pilonidal disease.

Exclusion Criteria

I am unable to understand or answer questions due to an intellectual disability.

Inability to read, write, or understand English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either regular epilation regimen only or regular epilation regimen with surgical excision

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Regular Epilation Regimen
• Surgical excision

Trial Overview The study compares two approaches: surgical removal of the affected area versus following a regular hair removal regimen, like laser epilation, after initial symptoms are resolved to see if surgery can be avoided.

How Is the Trial Designed?

Group I: Regular epilation regimen only Active Control 1 Intervention

Group II: Regular epilation regimen with surgical excision Active Control 2 Interventions

Surgical excision is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Pilonidal cystectomy for:

• Pilonidal disease with abscess
• Chronic pilonidal disease

Approved in United States as Pilonidal sinus excision for:

• Infected pilonidal cyst
• Recurrent pilonidal disease

Approved in Canada as Surgical removal of pilonidal disease for:

• Pilonidal disease with sinus tracts
• Chronic pilonidal abscess

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Minimally invasive treatments for chronic pilonidal sinus disease, such as phenolisation and laser therapy, are gaining popularity due to their benefits of reduced pain, quicker healing times, and faster return to work for patients.

For recurrent cases, more invasive options like skin advancement flap techniques may be necessary, but they come with higher risks of complications, while laser hair removal post-surgery can help lower the chances of the disease coming back.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chronic pilonidal sinus disease: overview of treatment options]. Pronk, AA., Furnée, EJB., Smakman, N.[2022]

In a study of 106 pediatric patients with pilonidal disease, the sinusectomy (SE) technique resulted in significantly faster healing times (20 days) compared to pit-picking plus laser ablation (PPL) which took 30 days (p = 0.002).

The overall complication rate was higher in the PPL group (9% vs. SE), although both techniques had similar recurrence rates (17% for PPL vs. 16% for SE, p = 0.89), indicating that SE may be a safer option with better healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of pilonidal sinus disease in a paediatric population: comparison of two techniques. Fernandes, S., Soares-Aquino, C., Teixeira, I., et al.[2022]

In a study of 351 patients with pilonidal sinus disease, sinusectomy with primary closure (SPC) resulted in significantly shorter hospital stays and faster wound healing compared to excision and primary closure (EPC).

SPC also demonstrated a lower recurrence rate of 5.5% compared to 18.7% for EPC, indicating that SPC may be a more effective surgical option for treating both primary and recurrent cases of pilonidal sinus disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sinusectomy and primary closure versus excision and primary closure in pilonidal sinus disease: a retrospective cohort study. Gul, VO., Destek, S.[2021]

In a study of 92 patients with degenerative spondylolisthesis who underwent surgery, 57.6% experienced no adverse events (AEs), while the most common intraoperative AEs were dural tears (6.5%) and bone-implant interface failures (3.3%).

Postoperative AEs were primarily infections, with urinary tract infections occurring in 10.9% of patients, and the risk of intraoperative AEs increased by 9% for each additional year of age, indicating that older patients may be at higher risk during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective analysis of adverse events in surgical treatment of degenerative spondylolisthesis. Kelly, AM., Batke, JN., Dea, N., et al.[2019]

The sinus excision technique for treating limited, chronic pilonidal disease is more efficient than the excision and marsupialization technique, requiring shorter operation times, hospital stays, and work-off periods, as shown in a study of 40 patients.

Patients who underwent the sinus excision technique reported higher satisfaction levels, with more individuals feeling 'completely satisfied' and willing to recommend the procedure compared to those who had the excision and marsupialization technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excision and marsupialization versus sinus excision for the treatment of limited chronic pilonidal disease: a prospective, randomized trial. Oncel, M., Kurt, N., Kement, M., et al.[2019]

In a study of 504 patients who underwent pilonidal sinus surgery, those who followed the recommendation for postoperative hair removal had a higher recurrence rate of the disease (30.1%) compared to those who did not remove hair (19.7%).

The findings suggest that using a razor for hair removal after surgery may actually increase the risk of long-term recurrence of pilonidal sinus disease, indicating that alternative hair removal methods, like laser treatment, should be explored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of postoperative razor epilation in pilonidal sinus disease. Petersen, S., Wietelmann, K., Evers, T., et al.[2014]

The ideal treatment for pilonidal sinus disease should ensure a quick recovery and minimal complications, but current surgical techniques still face challenges, particularly with wound healing.

This clinical review highlights the variability in management options for pilonidal sinus disease, indicating that while some techniques have improved outcomes, complications from surgery can still be significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of sacrococcygeal pilonidal sinus disease. Harries, RL., Alqallaf, A., Torkington, J., et al.[2021]

In a study of 924 skin lesion excisions, 7.25% of wounds developed infections, with ulceration and the use of antihypertensives identified as significant independent risk factors for infection.

Patients who did not wet their wounds post-operatively had a higher risk of infection, suggesting that wetting wounds with clean tap water may help reduce infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ulceration and antihypertensive use are risk factors for infection after skin lesion excision. Penington, A.[2022]

In a study of 19 children undergoing pilonidal sinus excision with primary midline closure, the recurrence rate requiring further surgery was 22%, indicating a significant risk of complications after this surgical technique.

The study also reported a high incidence of wound complications, with 44% experiencing wound dehiscence and 28% suffering from wound infections, suggesting that this technique may have higher morbidity in children compared to adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outcomes in pilonidal sinus disease. Braungart, S., Powis, M., Sutcliffe, JR., et al.[2022]

In a study of 80 patients with chronic pilonidal disease, sinus excision and primary closure led to significantly faster healing rates at 1 and 3 months post-surgery compared to the laying open technique.

However, by the 12-month follow-up, there was no significant difference in healing rates between the two methods, suggesting that while excision and closure may offer quicker initial recovery, the laying open technique is a safe, minimally invasive option that could be preferred for its lower risk profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sinus excision and primary closure versus laying open in pilonidal disease: a prospective randomized trial. Lorant, T., Ribbe, I., Mahteme, H., et al.[2012]

An automated tool for detecting surgical adverse events, specifically Surgical Site Infections (SSI), was developed to improve the efficiency of extracting postoperative outcomes from medical records, addressing the high costs associated with the manual NSQIP process.

The machine learning models created for this tool demonstrated high specificity (ranging from 0.788 to 0.988) and very high negative predictive values (over 0.98), effectively reducing the workload for NSQIP extractors by accurately identifying patients without SSIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Detection of Postoperative Surgical Site Infections Using Supervised Methods with Electronic Health Record Data. Hu, Z., Simon, GJ., Arsoniadis, EG., et al.[2018]

In a study of 106 patients undergoing 204 surgeries for impacted maxillary third molars, adverse events occurred in about 6.9% of cases, indicating a low frequency of complications during this common procedure.

The occurrence of these adverse events was significantly linked to the relationship of the second molar and the periodontal space, suggesting that these factors should be considered when assessing surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during the removal of impacted maxillary third molars. Carvalho, RW., Araújo-Filho, RC., Vasconcelos, BC.[2014]

In a study of 346 patients undergoing spinal surgery, 20.8% experienced at least one perioperative adverse event (AE), with pediatric patients showing a higher severity of AEs compared to adults.

Common AEs included dural tears and neuropathic pain in adults, while pediatric patients most frequently experienced neurologic deterioration; these AEs were associated with longer hospital stays, averaging an additional 6 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative adverse events in adult and pediatric spine surgery: A prospective cohort analysis of 364 consecutive patients. Lovi, A., Gallazzi, E., Galbusera, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11260285/

Preventing Pilonidal Sinus Recurrence With Laser Hair Epilation Laser hair epilation offers a way to reduce recurrence rates with reports within the current literature demonstrating positive outcomes compared to alternative ...

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2811756

Laser Epilation as an Adjunct to Standard Care in ... LE as an adjunct to standard care significantly reduced 1-year recurrence rates of pilonidal disease compared with standard care alone.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37938854/

Laser Epilation as an Adjunct to Standard Care in Reducing ... LE as an adjunct to standard care significantly reduced 1-year recurrence rates of pilonidal disease compared with standard care alone.

4. mdedge.com mdedge.com/pediatricnews/article/266781/pediatrics/laser-epilation-may-reduce-pilonidal-disease-recurrences

Laser epilation may reduce pilonidal disease recurrences ... At 1 year, 10.4% of the patients who had received LE plus standard treatment had experienced a recurrence of pilonidal disease, compared with ...

5. journals.lww.com journals.lww.com/aosopen/fulltext/2024/09000/heterogeneity_of_treatment_effects_of_laser.36.aspx

Heterogeneity of Treatment Effects of Laser Epilation on... The effectiveness of laser epilation to reduce pilonidal disease recurrence rates may vary based on race and ethnicity and insurance type.

6. jpedsurg.org jpedsurg.org/article/S0022-3468(25)00027-2/abstract

Laser Hair Removal May Be a Primary Treatment ... In this pilot study, nearly all treated patients had improvement in symptoms and quality of life, and 40 % resolved without surgical intervention. Laser hair ...