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

NCT06721169 | Recruiting

• 1 other identifier: 2024/883
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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'. 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.

Conditions

Pilonidal Sinus Disorder; Surgical Outcomes; Pilonidal Sinus Treatment

Keywords

Pilonidal Disease, Phenol, Laser Ablation

Outcome Measures

Primary Outcomes (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.

  7 day

Secondary Outcomes (3)

• Length of Hospital Stay

  7 day

• Return to Daily Activities

  7 day

• Recurrence of disease

  1 year

Study Arms (2)

Phenol

Patients with uncomplicated pilonidal sinus disease who receive phenol therapy will be included in this group.

Lazer ablation

Patients with uncomplicated pilonidal sinus disease who underwent laser ablation will be included in this group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, 33010, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 34291332 BACKGROUND

• 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.

  PMID: 32064640 BACKGROUND

• 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.

  PMID: 36700412 BACKGROUND

• 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.

  PMID: 31278458 BACKGROUND

• 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.

  PMID: 36856904 BACKGROUND

Study Officials

• Doğuş Parlak, PhD

  Mersin University

  STUDY DIRECTOR

Central Study Contacts

Hilmi Bozkurt, Assoc Prof

CONTACT

+905321780880; hilmibozkurt27@gmail.com

Doğuş Parlak, PhD

CONTACT

+905382848691; dogusparlak94@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 28, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be accessible from 6 months to 36 months after the publication of the article. Data access will be granted to researchers who submit a methodologically sound proposal and receive approval from an independent review committee. Proposals should be directed to the Mersin University Hospital Department of General Surgery.
• Access Criteria: To gain access, researchers will be required to sign a data access agreement and, if necessary, obtain relevant ethics approval. The study protocol, statistical analysis plan, informed consent form and clinical study report will also be provided. Data will be shared via a secure online platform with appropriate confidentiality and security measures in place.

Locations

TU (1)