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| ID | Type | Description | Link |
|---|---|---|---|
| 2024.077 | Other Identifier | ASz |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control cohort | Current practice cohort | ||
| Interventional cohort | Best practice care pathway with standardized Bascom cleft lift |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4-6 weeks and 6 months postoperative. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with (symptomatic) complex or recurrent pilonidal sinus disease, who will be planned for surgical treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Max Goudberg, MD | Contact | +31622577653 | m.r.goudberg@asz.nl |
| Name | Affiliation | Role |
|---|---|---|
| Robert Smeenk, MD, PhD | Albert Schweitzer Ziekenhuis, Netherlands | Principal Investigator |
| Boudewijn Toorenvliet, MD, PhD | Ikazia ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Schweitzer ziekenhuis | Recruiting | Dordrecht | 3318AT | Netherlands |
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| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
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| Pain | Pain score, on a Numeric Rating Scale ranging from 0-10 with 0 representing 'no pain' and 10 representing 'the worst pain possible' | The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. |