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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• Succes rate of treatment [Срок оценки: 1 year]

Вторичные конечные точки (11)

• Success rate of treatment at long-term follow-up [Срок оценки: 3-5 years]
• Pain score [Срок оценки: 6 weeks]
• Patient reported outcome measures [Срок оценки: 5 years]
• Wound healing and complications [Срок оценки: 1 year]
• Work rehabilation [Срок оценки: 6 weeks]
• Return to daily activities [Срок оценки: 6 weeks]
• Recurrence rate [Срок оценки: 5 years]
• Need for secondary or revision surgery [Срок оценки: 5 years]
• Patient satisfaction [Срок оценки: 5 years]
• Quality adjusted life years (QALYs) [Срок оценки: 5 years]
• Absence of symptoms [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 34993686

Идентификаторы

NCT: NCT06140199 · NL84679.018.23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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