An interventional study of Pit-picking surgery and Pit-picking surgery with Sinus Laser assisted Closure in Pilonidal Sinus, Pilonidal Disease and Pilonidal Sinus of Natal Cleft, sponsored by dr. IJM Han-Geurts. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by dr. IJM Han-Geurts · Not applicable, Interventional, and Treatment
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:
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 482 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →dr. IJM Han-Geurts is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Pit-picking surgery
Procedure: Pit-picking surgery with Sinus Laser assisted Closure
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.
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.
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.
Time frame: 1 year
Success rate of treatment at long-term follow-up
Success rate of treatment at 3 and 5 years follow up
Time frame: 3-5 years
Pain score
Pain scores in the period after surgery (VAS). VAS score scale: 0-10, higher score meaning a worse outcome.
Time frame: 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.
Time frame: 5 years
Wound healing and complications
Wound and complications
Time frame: 1 year
Work rehabilation
Work rehabilitation; number of days
Time frame: 6 weeks
Return to daily activities
Time until return to daily activities; number of days
Time frame: 6 weeks
Recurrence rate
Recurrence rate at 1, 3 and 5 years of follow-up
Time frame: 5 years
Need for secondary or revision surgery
Need for seondary or revision surgery for pilonidal disease
Time frame: 5 years
Patient satisfaction
Patient satisfaction with treatment (scored on a likert scale 0-10, with a higher score meaning a better outcome)
Time frame: 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)
Time frame: 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?
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No — On reasonable request.
Start is estimated for Aug 2024; primary completion for May 2027, 33 months later.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 33 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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dr. IJM Han-Geurts