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| Name | Class |
|---|---|
| Flevoziekenhuis | OTHER |
| Proctos Kliniek | OTHER |
| Sint Jans Gasthuis Weert | UNKNOWN |
| UMC Utrecht |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pit-picking surgery | Active Comparator |
| |
| Pit-picking surgery with Sinus Laser assisted Closure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pit-picking surgery | Procedure | 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. |
| 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 |
| 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). VAS score scale: 0-10, higher score meaning a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin Youp van Oostendorp, MD MSc | Contact | +31613780223 | j.vanoostendorp@proctoskliniek.nl | |
| Robert Smeenk, MD PhD | Contact | r.m.smeenk@asz.nl |
| Name | Affiliation | Role |
|---|---|---|
| Robert Smeenk, MD PhD | Albert Schweitzer Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34993686 | Result | 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. |
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On reasonable request.
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| OTHER |
| Ziekenhuis Amstelland | OTHER |
| Treant ziekenhuis | UNKNOWN |
| Albert Schweitzer Hospital | OTHER |
Multicentre, single-blinded, randomised, controlled, superiority trial. It
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Only the outcome assessor is blinded.
|
| Pit-picking surgery with Sinus Laser assisted Closure | Procedure | 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. |
|
| 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 |
| Wound healing and complications | Wound and complications | 1 year |
| 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 |
| 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 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 |
| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
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