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

Trial Summary

What is the purpose of this trial?

The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation.

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.

What data supports the effectiveness of the treatment for pilonidal disease?

Research shows that sinus excision techniques, which are part of the surgical options for pilonidal disease, can lead to shorter operation times, hospital stays, and recovery periods, with better patient satisfaction compared to other surgical methods. Additionally, postoperative hair removal has been studied for its potential to reduce the recurrence of pilonidal disease. ^{1 2 3 4 5}

Is surgery for pilonidal disease generally safe?

The research articles provided do not contain specific safety data for surgery or hair removal treatments for pilonidal disease. ^{6 7 8 9 10}

How does surgical excision differ from other treatments for pilonidal disease?

Surgical excision for pilonidal disease involves removing the affected tissue, which can lead to tissue loss and potential healing issues, unlike minimally invasive techniques that aim to reduce pain and speed up recovery. This approach is often used when other treatments are not effective, especially in chronic or recurrent cases. ^{2 5 11 12 13}

Research Team

Bill Chiu, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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]

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 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]

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 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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Excision and marsupialization versus sinus excision for the treatment of limited chronic pilonidal disease: a prospective, randomized trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Sinus excision and primary closure versus laying open in pilonidal disease: a prospective randomized trial. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of postoperative razor epilation in pilonidal sinus disease. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Management of sacrococcygeal pilonidal sinus disease. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Sinusectomy and primary closure versus excision and primary closure in pilonidal sinus disease: a retrospective cohort study. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Perioperative adverse events in adult and pediatric spine surgery: A prospective cohort analysis of 364 consecutive patients. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Automated Detection of Postoperative Surgical Site Infections Using Supervised Methods with Electronic Health Record Data. [2018]

9. Denmark pubmed.ncbi.nlm.nih.gov

Adverse events during the removal of impacted maxillary third molars. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Prospective analysis of adverse events in surgical treatment of degenerative spondylolisthesis. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Improving outcomes in pilonidal sinus disease. [2022]

12. Australia pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of pilonidal sinus disease in a paediatric population: comparison of two techniques. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

[Chronic pilonidal sinus disease: overview of treatment options]. [2022]