Pilonidal SinusLA POPANCT06140199
Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)
A study testing Pit-picking surgery and Pit-picking surgery with Sinus Laser assisted Closure in people with Pilonidal Sinus and Pilonidal Disease, run by dr. IJM Han-Geurts.
Trial 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 older with primary pilonidal sinus disease. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pilonidal Sinus, Pilonidal Disease, Pilonidal Sinus of Natal Cleft
- What is being tested?
- Pit-picking surgery and Pit-picking surgery with Sinus Laser assisted Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2024to May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Robert Smeenk, MD PhD contact
About this study
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:
Read more
- 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.
- Conditions
- Pilonidal Sinus, Pilonidal Disease, Pilonidal Sinus of Natal Cleft, Pilonidal Disease of Natal Cleft, Pilonidal Sinus Without Abscess
- Being tested
- Pit-picking surgery, Pit-picking surgery with Sinus Laser assisted Closure
- Keywords
- Pit-picking, Laser-assisted therapy, SiLaC, Minimally invasive surgery
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pit-picking surgeryProcedure or surgery
Patients are placed in left-side position. After shaving, cleaning and scrubbing of the skin with alcoholic chlorhexidine, double strong tape is placed on the right buttock in order to increase exposure. Local anaesthesia is administered before incision with 20 ml xylocaine or lidocaine 1-2%. In principle, all sinusoidal pits are cut out with a margin of at least 1 mm with a biopsy core punch (4 mm, 6 mm or 8 mm depending on pit size) or an oval excision of the pits is performed. Hair and debris is removed from the sinus tracts with a small surgical spoon or mosquito clamp. Rigorous de-epithelialisation of the underlying sinus is performed with the spoon through every pit, whilst removing even more debris and hairs. At the end of the procedure a debris washout is performed with saline solution, the wounds are left open for secondary healing and sterile dressings are applied.
Pit-picking surgery with Sinus Laser assisted ClosureProcedure or surgery
The pit picking procedure is described above. Subsequently, a radial diode laser probe at 1470 nm wavelength is used for delivering homogeneous (360 degrees) energy to the surrounding epithelium. The laser energy is 13 Joule, given continuously. First, a 'preparatory laser treatment' is performed to extract any missed hairs or debris, after which the sinus tracts are cleansed with a surgical spoon again. During the following definitive procedure, the probe is withdrawn at an approximate speed of 1 cm per three seconds, causing the small sinus tracts to shrink and close. Large sinus tracts remain open because very large sinus tracts or cavities cannot be closed with the 3mm laser fibre. The injury to the endothelium will cause granulation and create oedema for collapsing of the tract. The remaining open wounds are left open for secondary healing and sterile dressings are applied.
| Study group | Role | What they receive |
|---|---|---|
| Pit-picking surgery | Active comparator | Not described Receives: Procedure: Pit-picking surgery |
| Pit-picking surgery with Sinus Laser assisted Closure | Experimental | Not described Receives: Procedure: Pit-picking surgery with Sinus Laser assisted Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succes rate of treatment
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.
Measured: 1 year
Secondary outcomes (11)
Success rate of treatment at long-term follow-up
Success rate of treatment at 3 and 5 years follow up
Measured: 3-5 years
Pain score
Pain scores in the period after surgery (VAS). VAS score scale: 0-10, higher score meaning a worse outcome.
Measured: 6 weeks
Patient reported outcome measures
PROMs, defined as persisting complaints: itching, wound fluid leakage, blood loss, pus, pain, social burden (shame/embarrassment). PROMs will be scored on a scale: 1-5, with a higher score meaning a worse outcome.
Measured: 5 years
Wound healing and complications
Wound and complications
Measured: 1 year
Work rehabilation
Work rehabilitation; number of days
Measured: 6 weeks
Return to daily activities
Time until return to daily activities; number of days
Measured: 6 weeks
Recurrence rate
Recurrence rate at 1, 3 and 5 years of follow-up
Measured: 5 years
Need for secondary or revision surgery
Need for seondary or revision surgery for pilonidal disease
Measured: 5 years
Patient satisfaction
Patient satisfaction with treatment (scored on a likert scale 0-10, with a higher score meaning a better outcome)
Measured: 5 years
Quality adjusted life years (QALYs)
Quality of life after treatment (Eq-5d-5l; will be converted to Quality adjusted life years (QALYs; range 0-1, with 1 the highest score and the better outcome)
Measured: 5 years
Absence of symptoms
Absence of symptoms at 1-yars follow-up: participants will be asked a dichotomous question during their 1-year follow-up appointment. At that moment, do they feel their symptoms from pilonidal sinus disease are: A) cured or improved when compared with before treatment? or B) unchanged or worse when compared with before treatment?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start28 Aug 2024 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, single-blinded, randomised, controlled, superiority trial. It
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dr. IJM Han-Geurts
- Sponsor type
- University, hospital or other
- Collaborators
- Flevoziekenhuis, Proctos Kliniek, Sint Jans Gasthuis Weert, UMC Utrecht, Ziekenhuis Amstelland, Treant ziekenhuis, Albert Schweitzer Hospital
- Responsible party
- Sponsor-investigator, dr. IJM Han-Geurts, Proctos Kliniek
- Investigators
- Robert Smeenk, MD PhD, Principal investigator, Albert Schweitzer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140199
- Sponsor's protocol ID
- NL84679.018.23
- Acronym
- LA POPA
- Status last verified
- Aug 2024
- First submitted
- 14 Nov 2023
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On reasonable request.
Publications
Sluckin TC, Hazen SJA, Smeenk RM, Schouten R. Sinus laser-assisted closure (SiLaC(R)) for pilonidal disease: results of a multicentre cohort study. Tech Coloproctol. 2022 Feb;26(2):135-141. doi: 10.1007/s10151-021-02550-4. Epub 2022 Jan 7.
PubMed 34993686
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)
- ClinicalTrials.gov ID
- NCT06140199
- Acronym / sponsor ID
- LA POPA / NL84679.018.23
- Conditions
- Pilonidal Sinus, Pilonidal Disease, Pilonidal Sinus of Natal Cleft, Pilonidal Disease of Natal Cleft, Pilonidal Sinus Without Abscess
- Keywords
- Pit-picking, Laser-assisted therapy, SiLaC, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- dr. IJM Han-GeurtsUniversity, hospital or other
- Collaborators
- Flevoziekenhuis, Proctos Kliniek, Sint Jans Gasthuis Weert, UMC Utrecht, Ziekenhuis Amstelland, Treant ziekenhuis, Albert Schweitzer Hospital
- Study start
- 28 Aug 2024 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, single-blinded, randomised, controlled, superiority trial. It
| Arm | Type | Receives |
|---|---|---|
| Pit-picking surgery | Active comparator | Procedure: Pit-picking surgery |
| Pit-picking surgery with Sinus Laser assisted Closure | Experimental | Procedure: Pit-picking surgery with Sinus Laser assisted Closure |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pit-picking surgeryPatients are placed in left-side position. After shaving, cleaning and scrubbing of the skin with alcoholic chlorhexidine, double strong tape is placed on the right buttock in order to increase exposure. Local anaesthesia is administered before incision with 20 ml xylocaine or lidocaine 1-2%. In principle, all sinusoidal pits are cut out with a margin of at least 1 mm with a biopsy core punch (4 mm, 6 mm or 8 mm depending on pit size) or an oval excision of the pits is performed. Hair and debris is removed from the sinus tracts with a small surgical spoon or mosquito clamp. Rigorous de-epithelialisation of the underlying sinus is performed with the spoon through every pit, whilst removing even more debris and hairs. At the end of the procedure a debris washout is performed with saline solution, the wounds are left open for secondary healing and sterile dressings are applied. | Procedure or surgery | Pit-picking surgery |
| Pit-picking surgery with Sinus Laser assisted ClosureThe pit picking procedure is described above. Subsequently, a radial diode laser probe at 1470 nm wavelength is used for delivering homogeneous (360 degrees) energy to the surrounding epithelium. The laser energy is 13 Joule, given continuously. First, a 'preparatory laser treatment' is performed to extract any missed hairs or debris, after which the sinus tracts are cleansed with a surgical spoon again. During the following definitive procedure, the probe is withdrawn at an approximate speed of 1 cm per three seconds, causing the small sinus tracts to shrink and close. Large sinus tracts remain open because very large sinus tracts or cavities cannot be closed with the 3mm laser fibre. The injury to the endothelium will cause granulation and create oedema for collapsing of the tract. The remaining open wounds are left open for secondary healing and sterile dressings are applied. | Procedure or surgery | Pit-picking surgery with Sinus Laser assisted Closure |
Primary outcome
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.
11 secondary outcomes
Success rate of treatment at long-term follow-up
Time frame: 3-5 years
Pain score
Time frame: 6 weeks
Patient reported outcome measures
Time frame: 5 years
Wound healing and complications
Time frame: 1 year
Work rehabilation
Time frame: 6 weeks
Return to daily activities
Time frame: 6 weeks
Recurrence rate
Time frame: 5 years
Need for secondary or revision surgery
Time frame: 5 years
Patient satisfaction
Time frame: 5 years
Quality adjusted life years (QALYs)
Time frame: 5 years
Absence of symptoms
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Results publication: PubMed 34993686Sluckin TC, Hazen SJA, Smeenk RM, Schouten R. Sinus laser-assisted closure (SiLaC(R)) for pilonidal disease: results of a multicentre cohort study. Tech Coloproctol. 2022 Feb;26(2):135-141. doi: 10.1007/s10151-021-02550-4. Epub 2022 Jan 7.
- Individual participant dataSharing planned: No. On reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Smeenk, MD PhD contact
Robert Smeenk, MD PhD principal investigator
Albert Schweitzer Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Pit-picking surgery and Pit-picking surgery with Sinus Laser assisted Closure in people with Pilonidal Sinus and Pilonidal Disease, run by dr. IJM Han-Geurts.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Youp van Oostendorp, MD MSc (+31613780223, j.vanoostendorp@proctoskliniek.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Succes rate of treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06140199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.