An observational study in Pilonidal Sinus Treatment, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Observational
This study compares three different treatments for pilonidal sinus disease to determine which approach provides the best outcomes for patients.
Pilonidal sinus is a condition where a small hole or tunnel forms in the skin at the top of the buttocks. It happens when hair gets trapped under the skin, causing pain, swelling, and infection. This condition mainly affects young adults and can interfere with work and daily activities.
The study compares three minimally invasive treatments:
Researchers will measure healing rates, healing time, recurrence rates, pain levels, complications, patient satisfaction, and return to normal activities.
This research is important because there is no single "best" treatment for pilonidal sinus. Traditional surgery often requires general anesthesia, hospital stays, large wounds taking months to heal, significant scarring, long work absence, and high recurrence rates up to 30%.
These newer treatments offer faster healing, less pain and scarring, quicker return to normal life, and lower recurrence chance. By comparing these approaches directly, this study will help doctors and patients make better treatment decisions based on scientific evidence.
This is a prospective observational cohort study following patients who receive one of these three treatments. The study will include adults with pilonidal sinus disease suitable for minimally invasive treatment.
Detailed Description şu şekilde olmalı (sample size dahil):
STUDY DESIGN AND METHODOLOGY
This prospective observational cohort study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Department of General Surgery. The study aims to compare the clinical outcomes of three different minimally invasive treatment approaches for pilonidal sinus disease.
TREATMENT GROUPS
Group 1 - Laser Therapy: Patients will receive diode laser treatment using a radial fiber inserted into the pilonidal sinus tract. The procedure is performed under local anesthesia with lidocaine injection.
Group 2 - Phenol Treatment: Patients will receive crystallized phenol application into the sinus cavity after debridement of hair and debris. The procedure is performed under local anesthesia.
Group 3 - Combined Treatment: Patients will receive both laser therapy followed by phenol application in the same session under local anesthesia.
SAMPLE SIZE
This is a pilot comparative study designed to evaluate the feasibility and preliminary efficacy of three treatment approaches. Sample size will be determined based on patient availability and recruitment capacity during the study period. All eligible patients meeting inclusion criteria will be enrolled consecutively.
FOLLOW-UP SCHEDULE
Patients will be evaluated at 1 week, 1 month, 3 months, 6 months, and 12 months post-treatment.
PRIMARY ENDPOINTS
SECONDARY ENDPOINTS
STATISTICAL ANALYSIS
Categorical variables will be analyzed using Chi-square test. Continuous variables will be analyzed using appropriate parametric or non-parametric tests. Kaplan-Meier survival analysis will be used for time-to-healing assessment.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 165 is above the median of 145 across 37 observational studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 41 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with chronic pilonidal sinus disease seeking treatment at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Department of General Surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving diode laser treatment alone for pilonidal sinus disease
Patients receiving crystallized phenol application alone for pilonidal sinus disease
Patients receiving both laser therapy and phenol treatment in combination for pilonidal sinus disease
Complete Healing Rate
Complete Healing Rate
Time frame: 6 months
Recurrence Rate
Percentage of patients experiencing recurrence of pilonidal sinus disease defined as reappearance of symptoms, discharge, or new sinus formation at the treatment site
Time frame: 12 months
Time to Complete Healing
Time in weeks from treatment to complete healing
Time frame: Up to 12 months
Post-operative Pain Score
Pain intensity measured using Visual Analog Scale (VAS) ranging from 0-10
Time frame: 1 week, 1 month, 3 months
Complication Rate
Percentage of patients experiencing treatment-related complications
Time frame: 12 months
Plan to share: No — IPD will not be shared due to patient privacy protection requirements under Turkish data protection laws and the small sample size of this single-center study. Study results will be shared through scientific publications.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital