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NCT06140199: LA POPA
Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)
NA trial testing Pit-picking surgery in Pilonidal Sinus in 482 participants. Not yet recruiting.
1 May 2027
Quick facts
| Lead sponsor | dr. IJM Han-Geurts |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 482 |
| Start date | 28 August 2024 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 May 2032 |
Drugs / interventions tested
- Pit-picking surgery
- Pit-picking surgery with Sinus Laser assisted Closure
Conditions studied
- Pilonidal Sinus — all drugs for Pilonidal Sinus →
- Pilonidal Disease — all drugs for Pilonidal Disease →
- Pilonidal Sinus of Natal Cleft — all drugs for Pilonidal Sinus of Natal Cleft →
- Pilonidal Disease of Natal Cleft — all drugs for Pilonidal Disease of Natal Cleft →
Sponsor
dr. IJM Han-Geurts
Who can join
12 and older, any sex, with Pilonidal Sinus or Pilonidal Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Succes rate of treatment
Time frame: 1 year
Success rate of treatment, defined as closure of all pits at 1 year follow-up. Closure of the pits will be assessed by the treating surgeon by means of an extensive physical examination.
Sponsor's own description
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 older with primary pilonidal sinus disease. The main questions it aims to answer are: * The overall success rate of treatment which is defined as: closure of all pits at 12 months of follow-up. * Secondary endpoints: succes rat eof treatment during long-term follow-up, wound closure time, pain scores, complication rate, work rehabilitation, time to return to daily activities, quality of life, persisting complaints, patient satisfaction, costs and the need for secondary or revision surgery. Participants will allocated to pit picking alone or combined with lasertherapy. The extra burden for participating patients is expected to be minimal to moderate. Participants will have two extra hospital visits in casethey are enrolled in our study: 6 and 12 months after enrolment. Postoperatively the normal scheme of follow up appointments wil be used: 2 and 6 weeks after treatment at the outpatient clinic of the treating surgeon. A telephone appointment with the researcher will be scheduled 4 weeks after treatment. Patients are asked to complete questionnaires at various time points, which will be sentto them by email and will take approximately 5-10 minutes each time. The content includes general and disease specific Quality of Life (QoL) questionnaires. The investigators do not expect any extra adverse reactions or events in respect to participation in the study because both procedures are considered standard of care in the participating clinics. However, because both interventions are surgical procedures a small percentage of adverse events or postoperative complications can be expected.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06140199
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pilonidal Sinus
Currently open trials in the same condition.
- NCT07369921 — Pediatric Pilonidal Sinus Surgical Treatment · NA · recruiting
- NCT07314632 — Prospective Study in Laser Treatment of Pilonidal Cysts · recruiting
- NCT06286397 — Topical Anti-Androgens in Pilonidal Sinus Disease · Phase 2 · recruiting
- NCT06517472 — Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment · recruiting
- NCT06647290 — ENVELOP: Wound Care Following Pilonidal Sinus Surgery · NA · recruiting
Other dr. IJM Han-Geurts trials
Trials by the same sponsor.
- NCT05385887 — Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06140199 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by dr. IJM Han-Geurts
- Last refreshed: 28 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06140199.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing