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

Study Overview
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Brief Summary
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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, and the absence of symptoms,persisting sinuses or recurrence of pilonidal disease within 12 months. Secondary endpoints: wound closure time, patient experience, pain, complications, work rehabilitation, time to return to dailyactivities, quality of life, 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. Patients 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. We 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.

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

Conditions
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Pilonidal Sinus, Pilonidal Disease, Pilonidal Sinus of Natal Cleft, Pilonidal Disease of Natal Cleft, Pilonidal Sinus Without Abscess

Intervention / Treatment
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* Procedure: Pit-picking surgery
* Procedure: Pit-picking surgery with Sinus Laser assisted Closure


Participation Criteria
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Eligibility Criteria
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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 (11), see Figure 1 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentre, single-blinded, randomised, controlled, superiority trial. It
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pit-picking surgery<br> | Procedure: Pit-picking surgery<br>* 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.<br>|
| Experimental: Pit-picking surgery with Sinus Laser assisted Closure<br> | Procedure: Pit-picking surgery with Sinus Laser assisted Closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Succes rate of treatment | Success rate of treatment, defined as wound healing outcomes at 1 year, which includes the following: Closure of all pits Absence of symptoms Absence of persisting sinuses Absence of recurrence of pilonidal sinus disease | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of treatment at long-term follow-up | Success rate of treatment at 3 and 5 years follow up | 3-5 years | 
| Pain score | Pain scores in the period after surgery (VAS) | 6 weeks | 
| Patient reported outcome measures | PROMs, defined as persisting complaints: itching, wound fluid leakage, blood loss, pus, pain, social burden (shame/embarrassment | 5 years | 
| Wound healing and complications | Wound and complications | 1 year | 
| Work rehabilation | Work rehabilitation | 6 weeks | 
| Return to daily activities | Time until return to daily activities | 6 weeks | 
| Recurrence rate | Recurrence rate | 5 years | 
| Need for secondary or revision surgery | Need for seondary or revision surgery for pilonidal disease | 5 years | 
| Patient satisfaction | Patient satisfaction with treatment (scored on a likert scale) | 5 years | 
| Quality of life | Quality of life after treatment (Eq-5d) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pit-picking, Laser-assisted therapy, SiLaC, Minimally invasive surgery