Long-term Outcome of Radical Excision Versus Phenolization of the Sinus Tract in Primary Sacrococcygeal Pilonidal Sinus Disease: A Randomized Controlled Trial

BACKGROUND: Phenolization of pilonidal sinus disease has been shown to have advantages over radical excision with regard to short-term outcome; however, long-term outcomes are essentially lacking. OBJECTIVE: The aim of this randomized controlled trial was to compare the long-term outcome of pit excision and phenolization of the sinus tracts vs radical excision with primary wound closure in pilonidal sinus disease. DESIGN: Single-center, randomized controlled trial. SETTINGS: A primary teaching hospital in the Netherlands. PATIENTS: The study population included patients with primary pilonidal sinus disease presented between 2013 and 2017. INTERVENTIONS: Patients were randomly assigned to either pit excision with phenolization of the sinus tract(s) or excision with primary off-midline wound closure. MAIN OUTCOME MEASURES: The main outcomes included recurrence, quality of life (Short-Form 36), and patient's satisfaction. RESULTS: A total of 100 patients were randomized. Seventy-four patients (77.1%) were available for long-term follow-up. The mean (+/- SD) time to follow-up was 48.4 (+/- 12.8) months for the phenolization group and 47.8 (+/- 13.5) months for the excision group. No significant difference was found between both groups regarding quality of life. Two patients in the phenolization group (5.6%) and 1 in the excision group (2.6%) developed a recurrence (p = 0.604). The impact of the whole treatment was significantly less after phenolization (p = 0.010). CONCLUSIONS: Because of the previously shown favorable short-term results and the currently reported comparable long-term recurrence rate and quality of life between phenolization and excision, phenolization should be considered the primary treatment option in patients with pilonidal sinus disease.