Status:
NOT_YET_RECRUITING
Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)
Lead Sponsor:
dr. IJM Han-Geurts
Collaborating Sponsors:
Flevoziekenhuis
Proctos Kliniek
Conditions:
Pilonidal Sinus
Pilonidal Disease
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
The goal of this randomized clinical trial is to establish the efficacy of 'pit picking with laser therapy' versus 'pit picking alone' on both short and long-term outcomes in patients of 12 years and ...
Eligibility Criteria
Inclusion
- All patients aged 12 years and older who present with primary pilonidal sinus disease; Type 1b and 3 of the Dutch staging system
- Obtained written informed consent by the patient and/or legal representative/parent
- Sufficient understanding of the Dutch written language (reading and writing)
- Eligible for questionnaires sent by e-mail
Exclusion
- Asymptomatic (Type 1a), recurrent (Type 4; except those patients who only have had drainage of their abscess and no other surgical treatment), or chronic wounds (hypergranulating) after PSD surgery (Type 5) of the Dutch staging system
- Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the investigator, has the potential to significantly delay wound healing)
- Severe drug abuse (and therefore protocol deviation can be expected)
- Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- Patients with insufficient knowledge of the Dutch written language who are thus unable to answer the questionnaires
- Patients that are unable or not willing to give full informed consent
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2032
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT06140199
Start Date
August 28 2024
End Date
May 1 2032
Last Update
August 29 2024
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