Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA trial (Laser And Pit-picking OR Pit-picking Alone)

Recruiting

• Conditions: pilonidal cyst; Pilonidal sinus disease; 10002112

• Registration Number: NL-OMON56718
• Lead Sponsor: Albert Schweitzer Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 431

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: The overall success rate of treatment which is defined as:<br /><br>closure of all pits, and the absence of symptoms, persisting sinuses or<br /><br>recurrence of pilonidal disease within 12 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: wound closure time, patient experience, pain,<br />complications, work rehabilitation, time to return to daily activities, quality<br />of life, costs and the need for secondary or revision surgery.<br />Time points of measurement are defined as: T = 0 (baseline), 2 weeks, 4 weeks,<br />6 weeks, 6 months, 1, 3 and 5 year after treatment.</p>