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

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 Overview

• Status: Not yet recruiting
• Conditions: Pilonidal Sinus; Pilonidal Disease; Pilonidal Sinus of Natal Cleft; Pilonidal Sinus Without Abscess; Pilonidal Disease of Natal Cleft
• Intervention / Treatment: Procedure: Pit-picking surgery; Procedure: Pit-picking surgery with Sinus Laser assisted Closure

• Study Type: Interventional
• Enrollment (Estimated): 482
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Smeenk, MD PhD; Email: r.m.smeenk@asz.nl
• Study Contact Backup: Name: Justin Youp van Oostendorp, MD MSc; Phone Number: +31613780223; Email: j.vanoostendorp@proctoskliniek.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pit-picking surgery	Procedure: Pit-picking 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.
Experimental: Pit-picking surgery with Sinus Laser assisted Closure	Procedure: Pit-picking surgery with Sinus Laser assisted Closure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
Wound healing and complications	Wound and complications	1 year
Need for secondary or revision surgery	Need for seondary or revision surgery for pilonidal disease	5 years
Pain score	Pain scores in the period after surgery (VAS). VAS score scale: 0-10, higher score meaning a worse outcome.	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.	5 years
Work rehabilation	Work rehabilitation; number of days	6 weeks
Return to daily activities	Time until return to daily activities; number of days	6 weeks
Recurrence rate	Recurrence rate at 1, 3 and 5 years of follow-up	5 years
Patient satisfaction	Patient satisfaction with treatment (scored on a likert scale 0-10, with a higher score meaning a better outcome)	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)	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?	1 year

Collaborators and Investigators

• Sponsor: dr. IJM Han-Geurts
• Collaborators: UMC Utrecht; Albert Schweitzer Hospital; Flevoziekenhuis; Ziekenhuis Amstelland; Proctos Kliniek; Sint Jans Gasthuis Weert; Treant ziekenhuis
• Investigators: Principal Investigator: Robert Smeenk, MD PhD, Albert Schweitzer Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2032

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Minimally invasive surgery; Pit-picking; Laser-assisted therapy; SiLaC
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: NL84679.018.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: On reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No