Clinical trial NCT06517472: Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment
Official title: Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pilonidal Sinus
Keywords: Pilonidal sinus
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients aged 18 and older with pilonidal sinus disease and two or fewer pits, with no previous surgical treatment.

Brief summary: Pilonidal sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. In this study, three treatment methods will be performed: the minimally invasive pit-picking procedure, crystallized phenol application (CPT), and a combined method (minimally invasive pit-picking procedure and CPT). The aim of this study is to compare the effectiveness of these three methods, evaluate short- and long-term results, and determine treatment success, the incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the effects of these methods on hospital stay, wound healing time, and workforce loss will also be examined.

Detailed description: Pilonidal sinus disease (PSD) is common, affecting approximately 26 in 100,000 people. Treatment options and outcomes vary significantly. Chronic symptomatic pilonidal sinus disease primarily affects young adults and leads to substantial work loss. Due to the heterogeneous nature of clinical presentations, finding a single treatment approach for PSD has proven difficult. Future clinical studies might benefit from focusing on the best management strategies rather than the best technique.

Literature indicates that the minimally invasive pit-picking procedure has a general treatment success rate of 68%, with low postoperative complication rates, chronic pain, and high patient satisfaction regarding cosmetic appearance. It is seen as a better option in terms of pain, wound healing time, and complication rates. For simple, uncomplicated pilonidal sinus cases, the pit-picking method is an alternative to flap surgery in terms of wound healing and recurrence.

Particularly for patients with fewer than two pits and no lateral extensions, crystallized phenol application (CPT) is a good alternative to modified Limberg flap surgery and other surgical procedures. CPT, being a minimally invasive procedure performed under local anesthesia, has higher success rates after recurrent applications and shorter hospital stays. Long-term results for CPT treatment are also quite successful. Studies show that in addition to endoscopic pilonidal sinus treatment, crystallized phenol treatment is safe, well-tolerated, and provides quick and lasting recovery without recurrence over the follow-up period.

The presented study aims to compare the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, CPT Application, and Combined Pit Picking and CPT Application. The study will evaluate the short- and long-term results, treatment success, incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the study will examine the effects of these methods on hospital stay, wound healing time, and workforce loss. The presented study aims to determine whether minimally invasive procedures and CPT treatment offer better management strategies for pilonidal sinus disease. The findings are expected to contribute to identifying the most suitable treatment method for pilonidal sinus disease.

Eligibility criteria: Inclusion Criteria:

* Having two pits or less

Exclusion Criteria:

* With bilateral lateral extension,
* Stage-R with recurrent disease
* Number of pits more than three pits,
* Collagen tissue disease,
* Patients with a postoperative follow-up period of less than 12 months

Primary outcomes:
measure: Treatment Success
timeFrame: Up to 12 months post-treatment
measure: Postoperative Complications
timeFrame: Up to 3 months post-treatment.
Secondary outcomes:
measure: Recurrence Rate
timeFrame: Up to 12 months post-treatment
measure: Chronic Pain Level
timeFrame: Up to 3 months post-treatment
measure: Patient Satisfaction
timeFrame: Up to 12 months post-treatment
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
state: Other
Study officials:
References: