About this trial
The goal of this observational study is to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway, including a standardized cleft lift operation.
The main question it aims to answer is: Does a best practice care pathway with standardized cleft lift operation lead to shorter wound healing time and time to return to normal activities, compared to current standard care, with traditional excision techniques.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
16 years of age and older
Symptomatic complex or recurrent pilonidal sinus disease
Planned for surgical treatment
Signed informed consent
Disqualifiers
Pregnant
Insufficient understanding of the Dutch language or otherwise unable to give consent
Trial population
Patients with (symptomatic) complex or recurrent pilonidal sinus disease, who will be planned for surgical treatment.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Wound healing time
Time to wound healing (in days), this will be self reported by patients when the skin is completely closed, and will be validated through clinical assessment by the surgeon.
Secondary outcomes
Return to normal activities
Time to return to normal activities after surgery (in days). This will be self reported by patients through a brief checklist on which the activities (washing, dressing, sitting, work/study) should be checked when possible without discomfort.
Other outcomes
Quality of Life
Quality of Life, measured with EuroQol 5 dimensions, 5 levels (EQ-5D-5L) questionnaire. The questions are answered on a 5 point Likert scale. Ranging from 5-25, with 5 being the best possible outcome and 25 being the worst possible outcome. Additionally, there is a general question on a 0-100 scale, with 0 being the worst health possible and 100 being the best health possible.
Pain
Pain score, on a Numeric Rating Scale ranging from 0-10 with 0 representing 'no pain' and 10 representing 'the worst pain possible'
Sponsors and contacts
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