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Pilonidal Sinus TreatmentNCT06721169

Phenol or Laser: Best Minimally Invasive Treatment for Pilonidal Sinus?

An observational study of Pilonidal Sinus Treatment and Pilonidal Sinus Disorder, run by Mersin University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Pilonidal sinus disease is a common condition. There is still ongoing research on the ideal treatment. Pilonidal sinus disease is most common in men between the ages of 20 and 30. Read more about this study

Who is it for?
Ages 18 years and older
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Dec 2024to 15 Nov 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This prospective observational study will be conducted at the Department of General Surgery, Mersin University Hospital between December 15, 2024 and December 15, 2025. The study population consists of adult patients (≥18 years old) diagnosed with pilonidal sinus disease who are scheduled for surgical intervention.

Who may be able to join

  • Patients aged 18 years and older with pilonidal sinus disease
  • Patients who have not had any previous treatment for pilonidal sinus disease
  • Patients with uncomplicated pilonidal sinus
  • Having been diagnosed with pilonidal sinus disease
  • Patients whose descriptive and clinical characteristics are recorded in their medical files
  • Those who have signed the Informed Voluntary Consent Form/Written Consent Form

Who cannot join

  • Patients who have previously been treated for pilonidal sinus disease
  • Patients with complicated pilonidal sinus disease
  • Patients aged under 18
  • Patients whose descriptive and clinical characteristics are not recorded in their file records
  • Those who have not signed the Informed Voluntary Consent Form/Written Consent Form

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hilmi Bozkurt, Assoc Prof contact

+905321780880

hilmibozkurt27@gmail.com

Doğuş Parlak, PhD contact

+905382848691

dogusparlak94@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Mersin University

    Mersin, 33010

    Hilmi Bozkurt

    +905321780880, hilmibozkurt@mersin.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Minimally Invasive Treatment of Pilonidal Sinus Disease: Which is Better? Phenol or Laser Ablation

Pilonidal sinus disease is a common condition. There is still ongoing research on the ideal treatment. Pilonidal sinus disease is most common in men between the ages of 20 and 30. For patients with symptoms of pilonidal sinüs (pain, itching and discharge with soiling of underwear) that interfere with their normal daily life, several treatment options have emerged. A hairy body, thick skin, overweight, a deep gluteal cleft, lack of hygiene, sedentarism, repeated chafing and previous familial history are commonly admitted as predisposing factors.

There are various surgical and non-surgical methods for its treatment. Many different surgical techniques have been defined. None of these surgical techniques are defined as 'gold standard'.

Read more

For many years, wide excision and secondary healing was the standard approach for pilonidal sinus disease. However, when this method resulted in prolonged healing and restriction of regular activities, various reconstructive methods were developed to demonstrate the disadvantages of secondary healing.

A minimally invasive treatment modality for pilonidal sinüs dissease is excision of the sinus pit(s) followed by application of phenol to the sinus tract. Phenol is a sclerosing agent that destroys the epithelium and debris in the sinus, and is, thus, able to promote healing of the sinus.

Recently, advances in laser technology have made laser ablation of the sinus tract possible. The aim is to destroy and obliterate the sinus tracts with thermal energy produced by the laser probe.

The aim of this prospective observational study was to compare phenolization and laser ablation in the treatment of pilonidal sinus disease.

Read the detailed description

Pilonidal sinus disease refers to a subcutaneous infection occurring in the gluteal sulcus of the sacrococcygeal region. Although the cause is not clear, it is thought to be related to obesity, hairy body, and deep gluteal sulcus. The incidence of this acquired disease is about 26/100,000 subjects worldwide. The incidence rate among males is 4 times higher than that among females. Pilonidal sinus disease was first de scribed by Herbert Mayo in 1833 as a congenital condition, but is now accepted to be an acquired disease, given its absence in childhood .

Although its cause re mains unknown, the increased hormone levels associated with puberty, the growth of thick hair, long periods of sitting, and friction imparted by tight-fitting clothing may be in play. Other risk factors are hirsutism, obesity, and a family history of the disease. As the cause of the dis ease, hairs falling from head, neck, and back are placed in the intergluteal area and hairs that penetrate the skin initiate foreign body reactions. In the affected area, the hairs are moist, sweaty, and unhygienic, readily trig gering development of the subcutaneous skin cysts and sinuses characteristic of the disease, which (in the gluteal region) present as asymptomatic pits, painful abscesses, or sinuses associated with purulent serous discharge.

The acute phase is characterized by sacral abscess, and during the chronic phase cyst formation or persistent sinus discharge may be observed. At present, no consensus exists regarding the best treatment choice, but conservative treatment can only control the symptoms, and most patients have to undergo operation. Traditional surgery has good success rates; it requires removal of all diseased skin and subcutaneous tissue, including wide excision and healing by secondary intention or reconstructive ("flap") techniques, which results in a long recovery time and a large wound. In recent years, minimally invasive surgical methods for the treatment of SPD (such as endoscopic pilonidal sinus ablation, laser ablation, phenolization, or fibrin glue injection) have improved, reducing wound scarring and pain and shortening the time it takes for patients to return to their normal lives. Surgical success is evaluated by recovery time, the time to return to daily activities, and the complication and recurrence rates.

Patients presenting with pilonidal sinus disease at the Department of General Surgery, Mersin University (Türkiye) were evaluated for participation in this study. Patients aged ≥18 years with symptoms related to pilonidal sinus disease were included in this study. A power analysis was performed using the G*Power (v3.1.7) program to determine the sample size.

Exclusion criteria include the absence of symptoms associated with pilonidal sinus disease, suspicion of an extensive subcutaneous sinus tract network, and the presence of a pilonidal abscess and previous surgery for pilonidal sinus disease, recurrent and complicated pilonidal sinüs disease.

At least 64 patients who meet the inclusion and exclusion criteria will be included in this study. Appropriate surgical procedures will be applied to patients with pilonidal sinus disease who apply to Mersin University Hospital General Surgery Department. The method to be applied will be decided by discussing with the patient.

Data for this study will be collected between November 2024 and November 2025. During this period, data from patients who underwent surgery for pilonidal sinus disease at Mersin University Hospital General Surgery Clinic will be collected. Data will be collected from patients who apply for follow-up on the 1st day, 7th day, 6th month and 12th month after laser ablation or phenol treatment. Demographic characteristics, symptoms, clinical examination findings, surgical findings, postoperative VAS pain scores, wound complications, recurrence rates and return to daily life times will be examined. This data will be obtained through the retrospective review of medical records and confirmed by face-to-face interviews with patients who have attended the outpatient clinic, and then recorded in the data collection form.

Data collection will continue until at least 32 patients are reached in the phenolization and laser ablation groups. Once the target sample size is reached, new data collection from patients will be terminated and statistical analyses will be performed to compare prevalence between groups.

Keywords
Pilonidal Disease, Phenol, Laser Ablation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06721169
Study groupRoleWhat they receive
PhenolPatients with uncomplicated pilonidal sinus disease who receive phenol therapy will be included in this group.
Lazer ablationPatients with uncomplicated pilonidal sinus disease who underwent laser ablation will be included in this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Complications

    Postoperative complications will be assessed during a 7-day follow-up period. All complications will be documented during hospitalization and at scheduled follow-up visits, including surgical site infections, bleeding, and pulmonary complications.

    Measured: 7 day

Secondary outcomes (3)
  1. Length of Hospital Stay

    The duration of hospitalization will be measured from the day of surgery until discharge, with standardized discharge criteria including adequate pain control, successful oral intake and return of bowel function

    Measured: 7 day

  2. Return to Daily Activities

    The evaluation of the patients' return to their initial functional status will be evaluated using standardized questionnaires, either in person during outpatient clinic visits or over the phone (in cases where they do not come for regular follow-ups). This involves monitoring the time required to resume basic activities of daily living (ADLs) and reach preoperative functional capacity.

    Measured: 7 day

  3. Recurrence of disease

    Patients will be evaluated using standard questionnaires during their 6-month and 1-year outpatient clinic visits or by phone (in cases where they do not come for regular follow-ups). Patients will be evaluated for symptoms of recurrence (discharge, pain, abscess, new pit formation).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start28 Dec 2024
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion15 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
64 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06721169
Sponsor's protocol ID
2024/883
Status last verified
Jul 2026
First submitted
3 Dec 2024
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share de-identified individual participant data underlying the primary and secondary outcomes of the study, including demographics (age, gender, BMI), clinical parameters (pain, discharge, infection), surgical details, and postoperative outcomes.

Publications

  • Romic I, Augustin G, Bogdanic B, Bruketa T, Moric T. Laser treatment of pilonidal disease: a systematic review. Lasers Med Sci. 2022 Mar;37(2):723-732. doi: 10.1007/s10103-021-03379-x. Epub 2021 Jul 22.

    PubMed 34291332
  • Yardimci VH. Outcomes of Two Treatments for Uncomplicated Pilonidal Sinus Disease: Karydakis Flap Procedure and Sinus Tract Ablation Procedure Using a 1,470 nm Diode Laser Combined With Pit Excision. Lasers Surg Med. 2020 Nov;52(9):848-854. doi: 10.1002/lsm.23224. Epub 2020 Feb 17.

    PubMed 32064640
  • Elvira Lopez J, Escuder Perez J, Sales Mallafre R, Feliu Villaro F, Caro Tarrago A, Espina Perez B, Ferreres Serafini J, Jorba Martin R. Randomised clinical trial to test the phenolization in sacrococcygeal pilonidal disease. Int Wound J. 2023 Aug;20(6):2181-2189. doi: 10.1111/iwj.14096. Epub 2023 Jan 26.

    PubMed 36700412
  • Pronk AA, Smakman N, Furnee EJB. Short-term outcomes of radical excision vs. phenolisation of the sinus tract in primary sacrococcygeal pilonidal sinus disease: a randomized-controlled trial. Tech Coloproctol. 2019 Jul;23(7):665-673. doi: 10.1007/s10151-019-02030-w. Epub 2019 Jul 5.

    PubMed 31278458
  • Li Z, Jin L, Gong T, Qin K, Cui C, Wang Z, Wu J. An effective and considerable treatment of pilonidal sinus disease by laser ablation. Lasers Med Sci. 2023 Mar 1;38(1):82. doi: 10.1007/s10103-023-03741-1.

    PubMed 36856904

Questions about this trial

What is this clinical trial studying?

An observational study of Pilonidal Sinus Treatment and Pilonidal Sinus Disorder, run by Mersin University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hilmi Bozkurt, Assoc Prof (+905321780880, hilmibozkurt27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Complications (time frame: 7 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06721169, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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