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

Launched by DR. IJM HAN-GEURTS · Nov 14, 2023

Keywords

ClinConnect Summary

The LA POPA Trial is a clinical study designed to compare two treatments for a condition called pilonidal disease, which affects the area near the tailbone. Specifically, the trial will look at the effectiveness of a treatment called "pit picking with laser therapy" versus "pit picking alone." Both treatments aim to close the small cavities (or pits) caused by the disease. Researchers want to determine which method leads to better results over 12 months, including how quickly wounds heal, the level of pain experienced, and the overall satisfaction of patients.

To participate in this study, you need to be at least 12 years old and have primary pilonidal disease. If you join, you will have a couple of extra hospital visits for check-ups, but most of the follow-up will be routine. You’ll also fill out some questionnaires online about your health and quality of life after the treatment. While both treatments are standard procedures, there may be a small risk of complications, as with any surgery. This trial is not yet recruiting, but it offers an opportunity to contribute to important research that could improve treatment for future patients.

Gender

ALL

Eligibility criteria

• 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