Phenol or Laser: Best Minimally Invasive Treatment for Pilonidal Sinus?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMersin University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
64 Participants
are grouped into 2 trial groupsGroup A: Phenol
Group B: Lazer ablation
Trial outcomes
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.
Time frame
7 daySecondary outcomes
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
Time frame
7 day2
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.
Time frame
7 day3
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).
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov