Sinus pilonidalis (haarnestcyste in de bilspleet): fenolisatie (dichtbranden) vs. radical excisie (operatieve behandeling); een gerandomiseerde studie
Completed
- Conditions
- Sacrococcygeal Pilonidal Sinus DiseaseHaarnestcysteSinus pilonidalis
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1)Patient with symptoms due to chronic Sacrococcygeal Pilonidal Sinus Disease interfering with life (non-silent Sacrococcygeal Pilonidal Sinus Disease);
2)Age ≥ 18 years;
Exclusion Criteria
1)No or minimal symptoms related to Sacrococcygeal Pilonidal Sinus Disease;
2)Suspicion of extensive subcutaneous network of sinus tracts, especially in the case of more than three off-midline orifice, as these sinuses are not eligible for phenolisation treatment;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method oss of days of normal activities/ working days (measured from the start of the treatment).
- Secondary Outcome Measures
Name Time Method 1)Anatomic recurrence rate;<br /><br>2)Symptomatic recurrence rate (Visick satisfaction rate);<br /><br>3)Quality of Life (obtained by the Short Form-36 (SF-36) and visual analogue scale);<br /><br>4)Surgical site infection (cellulitis vs. abscess, treatment must be necessary to report a surgical site infection, i.e. antibiotics or opening of the wound) scored by the Southampton wound scoring system;<br /><br>5)Time-to-wound-closure (complete epithelisation);<br /><br>6)Symptoms related to treatment (fluid, pain, irritation, itch, burning);<br /><br>7)Pain (daily scored by a visual analogue scale during the first two weeks after each<br>operation; daily mean score after treatment and total days of pain determined);<br /><br>8)Usage of pain medication;<br /><br>9)Total treatment time (from start of treatment to cure of the Sacrococcygeal Pilonidal Sinus Disease);<br /><br>10)Sexual function (Sexual Self-Consciousness Scale, SSCS).